Search for: "FDA" - 469 articles found

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Sponsored • Infection management

New sepsis marker speeds up detection and therapy

Sepsis is the cause of one in five deaths worldwide, killing nearly 11 million people each year, many of them children. It is also a major cause of disability, affecting millions more. To combat the condition, many hospitals have implemented sepsis performance improvement programmes. A meta-analysis of 50 observational studies showed that these programmes are associated with better compliance…

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Artificial Intelligence

ScreenPoint Medical – Transpara

HighlightsScreenPoint Medical is the leading developer of AI driven image analysis technology for automated reading of 2D and 3D mammograms. Transpara is in clinical use in over 30 countries and is the most advanced commercially available multivendor AI solution (CE marked and FDA cleared for 2D and 3D). Find us at ECR 2022 or visit https://www.screenpoint-medical.com

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Article • Subset of wearables

From the wrist into the ear – the potential of hearables

Progress in miniaturising sensor technology has opened up new possibilities for monitoring vital signs outside the hospital environment. A subset of wearables are the so-called hearables – in-ear devices that are well suited for long-term monitoring as they are non-invasive, inconspicuous and easy to fasten. Hearables offer two major benefits: their proximity to the torso and vascular system of…

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Article • Key technologies

Artificial intelligence in medicine will prevail

Artificial intelligence (AI) is changing our healthcare systems. It can help us detect diseases earlier, improve patient care and reduce healthcare costs. However, there is still a lack of trust, of rules and safety regulations and of broad data pools. How can we use AI successfully in healthcare systems and what role will it play in the future?

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Identification/Susceptibility

Associates of Cape Cod – Fungitell STAT Assay

Highlights:  Fungitell, the gold standard in rapid screening for Invasive Fungal Infection (IFI), is now available in a single sample format. Fungitell STAT is the only single sample format FDA-cleared and CE marked rapid in vitro diagnostic screening test for IFI that detects (1→3)-β-D-glucan in serum.Test a single sample at a timeRapid in-house results – within one hour…

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Blood Glucose

Nova Biomedical – StatStrip Glucose/Ketone*

Highlights: The only glucose meter technology cleared by the US FDA across all professional and healthcare settings, including critical care.Measures and corrects glucose errors caused by abnormal haematocrit levelsMeasures and corrects errors caused by electrochemical interferencesMeasures blood beta-hydroxybutyrate, the preferred ketone for diagnosing ketoacidosisAvailable as a fully…

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Blood Cell Counter

Beckman Coulter – Early Sepsis Indicator

Highlights:A first-of-its-kind, hematology-based cellular biomarker, the FDA cleared Early Sepsis Indicator is designed to help emergency department physicians identify patients with sepsis or at risk of developing sepsis within 12 hours of ED presentation. Results are automatically reported as part of a routine complete blood count (CBC) with differential for adult emergency department…

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Infectious Disease/Hepatitis

Siemens Healthineers – Versant HCV Genotype 2.0 Assay (LiPA)

Highlights:Optimize your laboratory’s testing with the widely used Versant HCV Genotype 2.0 Assay (LiPA)*.LiPA utilizes reverse-hybridization technology to detect HCV genotypes 1–6 and subtypes 1a and 1b.LiPA provides highly accurate identification of HCV genotypes and subtypes for optimal and personalized patient therapy.* LiPA assay is FDA-approved in the U.S. and CE-marked in the…

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News • Conducting diagnostics

Detecting breast cancer via electrical currents in the skin

Mammograms are a safe, effective way to detect the presence of breast cancer in women. But doctors recommend most females should start getting mammograms after the age of 40 in part because the procedure involves small doses of ionizing radiation. While the risk of getting breast cancer is higher for older people, it can strike at any age. Studies show that 5% to 7% of females with breast cancer…

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News • Lights in the OR

New lighting solution improves illumination of surgical cavities

Vivo Surgical’s Klaro™ in vivo lighting device is designed to improve surgical illumination and provide a clearer view of surgical cavities. Developed in partnership with SingHealth – Singapore’s largest group of healthcare institutions – and Panasonic Lighting (Europe), this LED light solution solves many of the problems associated with traditional operating theatre lighting and…

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Sponsored • Photon-counting CT scanner

No detours, more detail

For the Siemens Healthineers team developing new and ever higher performing computed tomographs is daily fare. But when they introduced their most recent CT system an unusual sense of pride was palpable. The photon-counting detector in the new Naeotom Alpha scanner is different from previous models and achieves a level of detail hitherto unknown.

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Article • Mass spectrometry goes handheld

A pen to pin down the fringes of cancer

Mass spectrometry – a powerful tool for analysing the molecular composition of a tissue sample – is invaluable during cancer surgery. However, mass spectrometers are complex and unwieldy, and certainly a poor fit for an operating room (OR). To create a bridge between the lab and OR, Professor Livia S Eberlin, from Baylor College of Medicine, has developed a very special ‘pen’.

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News • Photon counting

Major CT advancement receives FDA clearance

The U.S. Food and Drug Administration (FDA) cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade. “Computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality; planning and guiding interventional or therapeutic procedures; and monitoring the effectiveness of certain therapies,” said…

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Article • A painful divorce

Post-Brexit worries for UK healthcare

Brexit could have a potential impact on healthcare delivery across the UK, according to an expert in the field. Dr Hugh Harvey believes that will be particularly noticeable in the area of Medical Device Regulation (MDR), with the UK and Europe seemingly going in different directions on the subject after the UK left the European Union (EU) at the end of last year.

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Article • Seeing the advantages

Digital pathology adoption accelerates

Digital pathology (DP) is a game-changer in the workflow, functionality and accessibility of a hospital’s pathology department. As pathologists understand the benefits, and the availability of commercial products and systems increase, alongside data transmission and storage costs decreasing, DP deployment in hospitals is accelerating. Pathology informatics expert Anil V Parwani MD PhD discussed…

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News • Clinical cardiovascular trials

Women still underrepresented in CVD research

Women remain underrepresented in cardiovascular clinical trials despite guidelines and legal requirements developed almost 30 years ago to ensure broader inclusivity. This is according to a report from the American College of Cardiology Cardiovascular Disease in Women Committee published in the Journal of the American College of Cardiology. This lack of representation can limit availability of…

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News • Controlling KRAS

New targeted gene therapy could stop lung cancer progression

A newly targeted therapy could help millions of lung cancer patients worldwide keep their cancers from spreading, says an expert at Cleveland Clinic, on the occasion of World Lung Cancer Day. Dr. Khaled Hassan, of the Hematology and Medical Oncology Department at Cleveland Clinic, explains the concept of KRAS targeted therapy – and why the approach should not be mistaken for a cancer cure.

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Article • Heard at SIIM 2021

AI in radiology: unexpected benefits, unintended consequences

Artificial intelligence (AI) could match the impact of PACS on radiology. Covid-19 stimulated the development and testing of AI diagnostic-aiding tools in radiology, an unintended consequence of the pandemic. More image data sets have been created to train AI software – an unexpected benefit for radiology research. The Samuel Dwyer Memorial Lecture at the virtual 2021 Society of Imaging…

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News • Self-powered implant

New device to speed up bone healing

Researchers know that electricity can help speed up bone healing, but “zapping” fractures has never really caught on, since it requires surgically implanting and removing electrodes powered by an external source. Now, researchers at the University of Wisconsin–Madison have expanded on this principle and developed a device to speed up bone healing.

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Article • Antibiotic resistance

Five-minute MRSA detection with aptasensor swabs

An international research team from Saudi Arabia, Germany, and Jordan has developed a novel pathogen aptasensor swab designed to qualitatively detect, within five minutes, any methicillin-resistant Staphylococcus aureus (MRSA) contamination that remains in a hospital isolation room or other surface following standard decontamination and cleaning.

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News • Sepsis detection

T2 Biosystems to participate at clinical conferences in June and July 2021

T2 Biosystems, Inc. announced the its participation in three virtual conferences this summer. The company, which specialises in the rapid detection of sepsis-causing pathogens, will take part in the American Society for Microbiology’s (ASM) and Federation of European Microbiological Societies’ (FEMS) World Microbe Forum; Sepsis Alliance’s inaugural Sepsis Tech and Innovation 2021…

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Aducanumab

FDA grants accelerated approval for Alzheimers drug

The U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.

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News • Fighting the pandemic

90 drugs against Covid-19

Mining the world's most comprehensive drug repurposing collection for Covid-19 therapies, scientists have identified 90 existing drugs or drug candidates with antiviral activity against the coronavirus that's driving the ongoing global pandemic.

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News • Battle for the brain

New Alzheimer's treatment approach targets tau

A new idea for treating Alzheimer’s disease could eradicate the toxic proteins most closely linked to cognitive decline in the places where they do the most damage, a study from researchers at Columbia University Vagelos College of Physicians and Surgeons suggests. The study was published online in Science Translational Medicine.

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News • Pancreatic ductal adenocarcinoma (PDAC)

Cutting-edge approach to fighting deadly form of pancreatic cancer

By 2030, the most lethal form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC), is projected to become the second leading cause of cancer-related deaths in the United States. Not only are therapeutic options limited, but nearly half of PDAC patients who have their tumors removed surgically experience disease recurrence within a year, even with chemotherapy. For more advanced stages,…

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News • AI-based technology

Image improvement with smart noise cancellation

Carestream Health has released Smart Noise Cancellation (SNC), a groundbreaking artificial intelligence (AI)-based technology that greatly improves image quality — producing images that are significantly clearer than with standard processing.

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News • Safe sonography

Medical societies support safety and benefits of ultrasound contrast agents

The American Institute of Ultrasound in Medicine (AIUM) and the American Society of Echocardiography (ASE) have joined the International Contrast Ultrasound Society (ICUS) in recognizing the relatively low risk and important clinical benefits of ultrasound contrast agents (UCAs), which are used routinely around the world to help detect heart disease, stratify the risk of heart attack or stroke,…

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News • Discerning good algorithms from bad ones

Medical AI evaluation is surprisingly patchy, study finds

In just the last two years, artificial intelligence has become embedded in scores of medical devices that offer advice to ER doctors, cardiologists, oncologists, and countless other health care providers. But how much do either regulators or doctors really know about the accuracy of these tools? A new study led by researchers at Stanford, some of whom are themselves developing devices, suggests…

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News • From foe to friend?

Some Alzheimer’s plaques may be protective, not destructive

One of the characteristic hallmarks of Alzheimer’s disease (AD) is the buildup of amyloid-beta plaques in the brain. Most therapies designed to treat AD target these plaques, but they’ve largely failed in clinical trials. New research by scientists at the Salk Institute upends conventional views of the origin of one prevalent type of plaque, indicating a reason why treatments have been…

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'GI Genius'

FDA authorizes marketing of first AI device to help colon cancer early detection

The U.S. Food and Drug Administration authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy. “Artificial intelligence has the potential to transform health care to better assist health care providers and…

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News • Diagnostics team-up

Cooperation to accelerate adoption of AI-powered digital pathology

Royal Philips and Ibex Medical Analytics announced a strategic collaboration to jointly promote their digital pathology and AI solutions to hospitals, health networks and pathology labs worldwide. The combination of Philips digital pathology solution (Philips IntelliSite Pathology Solution) and Ibex’s Galen AI-powered cancer diagnostics platform, currently in clinical use in Europe and the…

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News • Mammography support

AI solution may reduce interval breast cancer rates

Medical technology company iCAD, Inc. announced that ProFound AI for 2D Mammography might notably reduce the risk of interval breast cancer, according to a new retrospective analysis. The aim of the study was to determine if adding AI to reading mammography as a supportive tool may help in decreasing the interval cancer rate in population-based organized mammography screening programs in Germany.

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Harmony Transcatheter Pulmonary Valve (TPV) System

FDA approval for implant to treat congenital heart disease

The U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT). The device, called the Harmony Transcatheter Pulmonary Valve (TPV) System, is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without…

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Article • A significant opportunity for radiologists

Fostering a strong eco-system for AI in medical imaging

One of the leading figures in global radiology has highlighted the importance of fostering a strong eco-system to advance the safe and effective implementation of AI in medical imaging. Dr Geraldine McGinty said that to fully leverage the power of AI, all stakeholders must work together but underlined the unique responsibility physicians have to ensure patient interests are best served.

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News • Radiology congress in Vienna

Carestream showcases new detector, digital radiography solutions at Virtual ECR 2021

Carestream Health will highlight cutting-edge medical imaging technologies at the largest radiology meeting in Europe—the virtual European Congress of Radiology (ECR) in Vienna, Austria, beginning on March 3. The company will feature a wide range of products that demonstrates its leadership in digital medical imaging capture and processing, and improved user and workflow experiences.

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News • Target cells, medication effects, evasion methods

4 new facts about early Covid-19 infections

University of Minnesota Medical School researchers studied SARS-CoV-2 infections at individual cellular levels and made four major discoveries about the virus, including one that validates the effectiveness of remdesivir – an FDA-approved antiviral drug – as a form of treatment for severe Covid-19 disease. “Since the start of the Covid-19 pandemic, the way that each individual responds…

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News • Lessons learned from Covid-19

A 'blueprint' for preventing the next pandemic

Scientific and public health experts have been raising the alarm for decades, imploring public officials to prepare for the inevitability of a viral pandemic. Infectious epidemics seemingly as benign as "the flu" and as deadly as the Ebola virus provided ample warning, yet government officials seemed caught off guard and ill prepared for dealing with Covid-19.

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News • Restoring movement and ability

Brain implants: the key to mobility after stroke?

Someone has a stroke every 40 seconds in the US, resulting in death every 4 minutes. Stroke is the leading cause of disability from a medical condition. When it happens, blood clots or bleeds kill a part of the brain – it goes dark – and can no longer control part of the body. People stop being able to walk, see, talk, or control their hand or arm the way they once did. Although treatments…

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News • Frequently Asked Questions

What patients want to know about Covid-19 vaccine

This FAQ from the American College of Allergy, Asthma and Immunology is provided to help answer patient questions about COVID-19 vaccines. These recommendations are based on best knowledge to date, but could change at any time, pending new information and further guidance from the FDA or CDC.

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News • Coronavirus infection response

SARS-CoV-2 IgG II antibody test launched in CE Mark countries

Clinical diagnostics company Beckman Coulter launched its Access SARS-CoV-2 IgG II assay in countries accepting the CE Mark. The new Access SARS-CoV-2 IgG II assay quantitatively measures a patient’s level of antibodies in response to a previous SARS-CoV-2 infection. The ability to establish a quantitative baseline to evaluate an individual’s immune response to the SARS-CoV-2 virus allows…

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News • Measuring mitochondrial DNA

Rapid blood test identifies Covid-19 patients at high risk of severe disease

One of the most vexing aspects of the Covid-19 pandemic is doctors’ inability to predict which newly hospitalized patients will go on to develop severe disease, including complications that require the insertion of a breathing tube, kidney dialysis or other intensive care. Knowledge of a patient’s age and underlying medical conditions can help predict such outcomes, but there are still…

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Oversight of medical software

FDA Releases Artificial Intelligence/Machine Learning Action Plan

The U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software. “This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD,”…

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News • Detection of traumatic brain injury (TBI)

First rapid handheld blood test for concussions receives FDA clearance

Abbott has received 510(k) clearance for the first rapid handheld traumatic brain injury (TBI) blood test, which will help clinicians assess individuals with suspected mild TBIs, including concussions. The test will run on Abbott's handheld i-STAT Alinity platform. Tests results are available within 15 minutes after plasma is placed in the test cartridge. TBIs, including concussions, are an…

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News • Frontal part of the nose

Covid-19 Antigen Test: CE Mark for easier sample collection

Siemens Healthineers announced CE mark has been achieved to use anterior nose swab sampling for the Clinitest Rapid Covid-19 Antigen test. This sampling method can be less cumbersome and time consuming for both the provider and the patient. The test is a point-of-care cassette test that does not require laboratory instruments or specialized lab personnel to administer, and it delivers results in…

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News • Alternative to traditional surgery

Focused ultrasound shows promise for Parkinson’s treatment

A scalpel-free alternative to brain surgery has the potential to benefit people with Parkinson’s disease symptoms that are much more severe on one side of the body, new research suggests. More testing is needed, but the approach, which uses a technology called focused ultrasound, could offer a new option for patients whose symptoms are poorly controlled by medications and those who cannot or do…

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News • Promising candidate

Single-dose nanoparticle vaccine for Covid-19 in development

Before the pandemic, the lab of Stanford University biochemist Peter S. Kim focused on developing vaccines for HIV, Ebola and pandemic influenza. But, within days of closing their campus lab space as part of Covid-19 precautions, they turned their attention to a vaccine for SARS-CoV-2, the virus that causes Covid-19. Although the coronavirus was outside the lab’s specific area of expertise,…

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News • Point-of-care testing

epoc NXS Host Mobile Computer for POCT received CE, FDA clearance

Siemens Healthineers announced it has received CE Mark and 510(k) clearance from the U.S. Food and Drug Administration for the epoc NXS Host mobile computer. The epoc Blood Analysis System with the new epoc NXS Host offers an easy-to-use, hand-held device with intuitive software application to further advance point-of-care testing. The epoc NXS Host incorporates caregiver suggestions that enhance…

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Video • Resistance pulse

New study reveals how melanoma cells survive targeted therapies

In recent years, targeted therapies have cemented their place as some of the most important tools in cancer treatment. These medicines are designed to block specific signals that tumor cells use to grow and spread, while at the same time leaving normal cells unharmed. Targeted therapies can significantly extend patients’ lives, but the benefits are often only temporary. Over time, many cancers…

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Coronavirus Update

FDA Authorizes First Covid-19 and Flu Combination Test for Use with Home-Collected Samples

The U.S. Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both Covid-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC Covid-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for Covid-19 +Flu by individuals who are suspected of respiratory viral infection consistent…

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Article • Improving detection accuracy

Fighting prostate cancer with over 1.5 million MRI images

Men die about five years earlier than women across the world. As initiatives to boost awareness of men’s health unfolded in November, an international project is bringing the forefront of AI research to tackle prostate cancer (PC), the second most frequent type of cancer in men and the third most lethal in Europe.

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Article • USA and Chinese experts share observations

AI in Covid research

A panel of experts from the USA and China highlighted AI use in radiological workflow during the Covid pandemic and identified current pitfalls during the Hot Topic session at RSNA 2020. Radiologists from the USA prioritised Covid articles, delivered quick reviews, made all results open access, and helped organise a white paper from the Fleischner Society recognising recommendations for the role…

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News • Coronavirus assay receives CE Mark

Quantitative Covid-19 test to measure neutralizing antibodies

Siemens Healthineers announced its SARS-CoV-2 IgG Antibody Test (sCOVG) has proven to measure neutralizing antibodies and has achieved CE Mark. The test is an enhanced version of the assay which became available globally this summer. It demonstrates the ability to detect neutralizing antibodies and reports quantitative results measuring the amount of neutralizing antibodies present in a patient's…

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Article • Medical waste management

Time to “Green Up” for EU Ministries of Health

COVID-19 has rocked health care systems, revealing vulnerabilities in our supply chain, piling up unprecedented costs, and creating an alarming amount of medical waste. The health care sector was already a major source of pollution. The World Health Organization points to the burning and incineration of health care waste as a source of dioxins, furans, and particulate matter emissions that…

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News • Flaws in study design

Will COVID-19 vaccines save lives? Right now, we cannot tell

Vaccines are being hailed as the solution to the COVID-19 pandemic, but the vaccine trials currently underway are not designed to tell us if they will save lives, reports Peter Doshi, Associate Editor at The BMJ. Several COVID-19 vaccine trials are now in their most advanced (phase 3) stage, but what will it mean exactly when a vaccine is declared “effective”? Many may assume that successful…

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Video • List by top clinicians and researchers

Top 10 medical innovations for 2021

An up-and-coming gene therapy for blood disorders. A new class of medications for cystic fibrosis. Increased access to telemedicine. These are some of the innovations that will enhance healing and change healthcare in the coming year, according to a distinguished panel of clinicians and researchers from Cleveland Clinic. In conjunction with the 2020 Medical Innovation Summit, Cleveland Clinic…

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Video • Intelligent surgical unit

Advancing robotic surgery with machine vision capabilities

TransEnterix, Inc., a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, announced that Hackensack Meridian Health Pascack Valley Medical Center, a hospital in New Jersey, successfully completed its first surgical procedures using the Intelligent Surgical Unit (ISU).

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Article • Need for modernisation

Digital pathology: Luxury or necessity?

The anatomical pathologist faces a crisis. Public and private labs suffer increasing caseloads, whilst pathologist numbers diminish for various reasons, including greater cancer prevalence associated with aging populations as well as improved cancer screening programs. Precision medicine typically involves more genetic testing and extensive use of immunohistochemistry to classify cancer and…

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Article • Blood poisoning

Exploring the importance and challenges of early sepsis diagnosis

On the occasion of this year's World Sepsis Day, we spoke with Elena Sukhacheva, Ph.D., director of medical and scientific affairs at Beckman Coulter, about the status quo and outlook on sepsis diagnostics. With the severity of sepsis symptoms, it’s easy to comprehend why it is invaluable to diagnose this disease properly and in a timely manner. Dr Sukhacheva takes an in-depth look at…

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Article • Rapidly meeting a surging demand

The science behind 3-D printed nasal swabs

Medical device approved 3-D printers are producing clinically safe and effective nasopharyngeal swabs for COVID-19 testing. A nasal swab may seem rudimentary, but is essential for testing COVID-19. Diagnostic test kits and components – nasal swabs, collection vials, and chemical reagents – have been in short supply worldwide, especially in March. Ironically, nasopharyngeal swabs are…

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Article • Sterilising with VHP, EO or HPGP

Sterilisation study puts cleansing methods to the test

A new study from the USA highlights how low temperature sterilisation can jeopardise effective cleansing of medical tools and lead to transmission of dangerous bacteria to patients. Steam sterilisation was shown to be the most effective and robust sterilisation technology. However, the researchers, working at the University of North Carolina, also showed that vaporised hydrogen peroxide (VHP)…

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News • Lack of females

Sex biases in drug dose trials leads to overmedicated women

Women are more likely than men to suffer adverse side effects of medications because drug dosages have historically been based on clinical trials conducted on men, suggests new research from UC Berkeley and the University of Chicago. Researchers analyzed data from several thousand medical journal articles and found clear evidence of a drug dose gender gap for 86 different medications approved by…

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Article • Imaging informatics meeting

SIIM 2020: Glancing back at 40 years and ahead to the future

40 years ago, anticipating the huge impact of computers in radiology, a group of visionaries formed the Radiology Information System Consortium (RISC). In 1989, RISC created the Society for Computer Applications (SCAR) to promote computer applications in digital imaging. Those organisations became the Society for Imaging Informatics in Medicine (SIIM). At SIIM 2020, a virtual meeting, experts…

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News • Deep learning in imaging

1.5T MR system receives FDA clearance for AI-based image reconstruction technology

Canon Medical Systems USA, Inc. has received 510(k) clearance on its Advanced intelligent Clear-IQ Engine (AiCE) for the Vantage Orian 1.5T MR system, continuing to expand access to its new Deep Learning Reconstruction (DLR) technology. This technology, which is also available on the Vantage Galan 3T MR system and across a majority of Canon Medical’s CT product portfolio, uses a deep learning…

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News • Growth segment focus, resource optimization, massive restructuring

Healthcare experts: 2020 will be 'unforgiving but transformational'

Frost & Sullivan’s recent analysis, Post-Pandemic Global Healthcare Market Outlook, 2020, forecasts that 2020 will be an unforgiving but transformational year for the healthcare industry. As the world grapples with a global emergency caused by the COVID-19 pandemic, the healthcare industry is expected to witness a drop in growth from 5.3% to 0.6% in 2020, with revenues remaining below the…

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News • Rad Companion

Siemens expands AI portfolio in clinical decision-making

The AI-Rad Companion family supports radiologists, radiation oncologists, radiotherapists and medical physicists through automated post processing of MRI, CT and X-ray datasets. It saves the clinicians' time and helps them to increase their diagnostic precision.

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News • COVID-19

Four commercial immunoassay tests for detection of antibodies

Public Health England, in partnership with the University of Oxford, recently conducted a head-to-head evaluation of four commercial immunoassay tests available in the UK and used for the detection of SARS-CoV-2 antibodies.

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News • COVID-19 diagnostics

SARS-CoV-2 IgG antibody test receives FDA Emergency Use Authorization

Beckman Coulter announced that its Access SARS-CoV-2 IgG assay has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA). Beckman Coulter has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the U.S., and has begun distribution of the new antibody test globally to countries that accept the FDA EUA and CE Mark. The…

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Interview • Abbott cardiovascular

An increasingly dynamic cardiovascular presence

In the world of laboratory diagnostics, ‘Abbott’ is a household name. Few people however are aware of the fact that the company, headquartered in Illinois, USA, is also leading in other fields. A number of innovations in cardiac and vascular diagnostics and therapy might soon put Abbott in the limelight. Dr Angela Germer, Regional Director DACH, and Volker Keller, Head of Marketing DACH,…

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News • Viral on­co­logy

Kaposi Sarcoma: Answers to a longstanding enigma

The oncogenic herpesvirus (HHV8 or KSHV) causes a cancer known as Kaposi’s Sarcoma. An international team of scientists led by the University of Helsinki has discovered key factors that control the genome maintenance and replication of a virus responsible for lymphatic vascular cancer. Kaposi Sarcoma (KS) is the most common cancer among Aids patients and it is often seen in sub Saharan and…

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News • Heart attacks, heart failure, stroke

COVID-19’s cardiovascular complications

COVID-19 can cause serious cardiovascular complications including heart failure, heart attacks and blood clots that can lead to strokes, emergency medicine doctors at the University of Virgina report in a new scientific paper. They also caution that COVID-19 treatments can interact with medicines used to manage patients’ existing cardiovascular conditions.

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News • Estimating the 'Deep-Replicability' of scientific findings

AI speeds up search for COVID-19 treatments and vaccines

Researchers at Northwestern University are using artificial intelligence (AI) to speed up the search for COVID-19 treatments and vaccines. The AI-powered tool makes it possible to prioritize resources for the most promising studies — and ignore research that is unlikely to yield benefits. In the midst of the pandemic, scientific research is being conducted at an unprecedented rate. The Food and…

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Sponsored • Xenios consoles as lifesavers

ECMO: crucial in the battle against Covid-19

As the coronavirus spreads and infections with Covid-19 further increase throughout Europe, ECMO therapy turns out to be a necessary option for patients with severe courses. Xenios AG provides ECMO consoles that can be used for the treatment of patients who develop severe pneumonia and ARDS with lung failure which also might result from infection with the coronavirus.

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Article • More power for interventionists

Combining image-guided diagnosis and robot-assisted treatment

Siemens Healthineers AG took a big step last October. To incorporate treatment along an entire clinical path, the firm acquired Corindus Vascular Robotics, Inc., to combine image-guided diagnosis with robot-assisted surgery. A couple of months later, the Corindus endovascular robotic system CorPath GRX was used to implant a vascular stent into an obstructed coronary artery – the first use of…

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News • IgM/IgG identification

Coronavirus antibody test in development

In response to the global COVID-19 pandemic, Beckman Coulter announced that it is developing assays to identify IgM and IgG antibodies to the coronavirus or SARS-CoV-2. The assays will be designed for use on any of its high-throughput Access family of immunoassay systems, including the Access 2 and DxI series installed globally. Research has shown that after infection with SARS-CoV-2, viral…

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News • Blood gas testing

Aiding COVID-19 efforts: FDA clearance for blood gas analyzer

Siemens Healthineers announced that its latest critical care testing solution, the RapidPoint 500e Blood Gas Analyzer, has received clearance from the U.S. Food and Drug Administration (FDA), and is now available in the U.S., Europe and countries requiring the CE mark. The analyzer generates blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results, which are used to…

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Article • Bringing AI to the clinics

Pioneering a vendor neutral AI system

Capturing all the possibilities brought by AI long-seemed a faraway dream for hospitals, since most artificial intelligence (AI) solutions are vendor dependent, thus complicating their deployment in clinical practice. However, the dream has become reality at Utrecht UMC, which launched a pioneering AI infrastructure able to monitor information and run any algorithm from its HIS, RIS and PACS.…

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Article • Professor questions essential artificial intelligence safety

Facing facts: AI in clinical practice

Examining the safety of AI integration into clinical workflow during at the British Institute of Radiology (BIR) annual congress in London, this November, Professor Nicola Strickland focused on issues of data quantity and quality, regulation, validation and testing of algorithms. She also urged radiologists and computer scientists to work more closely together to develop safe, effective and…

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News • RT-PCR for COVID-19

First of 3 diagnostic tests for SARS-CoV-2 coronavirus available

Biotechnology company bioMérieux, a world leader in the field of in vitro diagnostics, is announcing the forthcoming launch of 3 different tests to address the COVID-19 epidemic and to meet the different needs of physicians and health authorities in the fight against this emerging infectious disease. bioMérieux has finalized the development of the SARS-CoV-2 R-Gene test. This real-time PCR test…

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News • Pandemic prevention

German lab developed coronavirus detection method

Investigators at Hannover Medical School (MHH) in Germany have developed a molecular assay for detecting the novel coronavirus SARS-CoV-2 (previously 2019-nCoV) on the automated Panther Fusion system by Hologic. The preclinical assay is described online in the Journal of Clinical Virology. “Rapid diagnosis is critical to combatting the spread of pandemics, and the Panther Fusion system is well…

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News • EUA for respirators issued

Coronavirus: U.S. permits more protective masks for healthcare setting

In a joint effort, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) take action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. This action allows certain National Institute for Occupational Safety and Health…

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News • Contrast & new biomarker

Detecting early-stage cancer with targeted MRI

A new method to detect cancer in its early stages using a targeted MRI contrast agent that binds to proteins has been identified by a team of researchers led by Georgia State University Regents’ Professor Jenny Yang. In their study, published in the journal Science Advances, Yang and her colleagues at Georgia State and Emory University describe a newly identified biomarker for detection of…

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News • After mastectomy

Promising approach for breast regeneration

A team of researchers from Osaka University, Kyoto Prefectural University of Medicine, and Toppan Printing Co., Ltd. succeeded in reconstructing adipose tissue balls (“mini-breasts”) with a functional vascular network using patient-derived cells, achieving a high graft survival rate in small animal models. So far, silicone breast implants were primarily used in breast reconstruction following…

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News • 3D radiography extension

FDA clearance for Digital Tomosynthesis

Carestream’s Digital Tomosynthesis (DT) functionality—a three-dimensional extension of general radiography—has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Simplifying workflow and reducing exam time, DT technology is an upgradable option on the Carestream DRX-Evolution Plus System, a versatile digital radiography system that can perform a wide range of…

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Video • PET precision brain imaging

‘Tau’ protein far more predictive for Alzheimer's damage than amyloid

Brain imaging of pathological tau-protein “tangles” reliably predicts the location of future brain atrophy in Alzheimer’s patients a year or more in advance, according to a new study by scientists at the UC San Francisco Memory and Aging Center. In contrast, the location of amyloid “plaques,” which have been the focus of Alzheimer’s research and drug development for decades, was found…

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Article • Lab advances against doping

A powerful tool for sports drug testing

Due to the scientific and technical developments in recombinant DNA technology and protein engineering since the early 1980s, therapeutic proteins have emerged as one of the most important classes of new pharmaceuticals. Currently, more than 200 protein and peptide based drugs have gained approval by the USA’s Food and Drug Administration (FDA) and many more are under preclinical or clinical…

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News • FDA launches off-label drug database

Cure ID: App finds new ways of treatment

The U.S. Food and Drug Administration (FDA) announced the global launch of Cure ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device. The platform enables the crowdsourcing of medical information from…

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Article • Evolution of technology

The value of AI in breast screening

Although breast cancer (BC) mammography screening enables early detection of breast cancer, mammography presents issues such as variability between the radiology readings and shortage of radiologists. This area of medical imaging is where artificial intelligence (AI) could help make the biggest difference and improve patient outcome.

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News • Smart devices and more

New GE imaging tech and intelligent apps unveiled at RSNA

At RSNA 2019, GE Healthcare launches more than 30 new, imaging intelligent applications and smart devices designed to drive efficiency in radiology departments, aiming to double productivity and cost savings for systems by 2025. For healthcare executives, the new offerings help systems to save costs, improve technology utilization, and increase patient volumes. Clinicians also will benefit from…

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News • Surgical planning, medical training, patient education

Mixed reality anatomy viewer released

Digital medical technology company Brainlab announced the launch of Mixed Reality Viewer, which brings spatial computing into daily clinical practice for surgical plan review, medical student training and patient consultation. Brainlab Mixed Reality (MR) Viewer uses the head-mounted display Magic Leap One from Brainlab strategic development partner Magic Leap to add a new dimension to patient…

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News • Vertebral body replacement (VBR)

Help for cervical spine

Omnia Medical’s ‘Boxcar’ has been granted the first US FDA 510(k) clearance for a cervical vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced polymer. The system has been designed for use in cervical-corpectomy procedures – the replacement of a collapsed, damaged, or unstable vertebral body located in the cervical spine. Robert Gewirtz, MD - Neurosurgeon,…

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Sponsored • NICO Myriad NOVUS resection tool

Xenon lighting for neurosurgery

NICO Corporation, a company based in Indianapolis, Indiana, is releasing its new Myriad Novus resection tool. The FDA cleared product combines xenon illumination with NICO’s proven Myriad neural tissue removal technology. Xenon lights reproduce the visible spectrum of daylight much better than most other bulbs – although LED contenders are now available – and so are often the optimal choice…

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Sponsored • A country encouraging intelligent medical innovations

Taiwan innovators shine at Medica

Health tech Made in Taiwan is among the mainstays of every MEDICA; this year’s fair is no exception. In co-operation with the Bureau of Foreign Trade (BOFT) of the Taiwanese Ministry of Economics and the Taiwan External Trade Development Council (TAITRA), 20 world-class healthcare companies are demonstrating innovative medical solutions based on national advances in Artificial Intelligence…

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News • Venous thromboembolism (VTE)

Award for new blood clot prevention technology

A partnership between the Royal Stoke University Hospital, part of the University Hospitals of North Midlands NHS Trust, and a UK industry-leading medical devices company have been rewarded for its use of an innovative bioelectronic technology to prevent life-threatening blood clots in acute stroke patients – winning in the category: Best use of technology (acute care), at the Building Better…

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News • Digital tomosynthesis

Carestream previews DT innovations at RSNA

Carestream will introduce a three-dimensional extension of general radiography through its Digital Tomosynthesis (DT) functionality (Pending FDA 510(k) clearance) at this year’s Radiological Society of North America conference in booth #7513, North Hall. Simplifying workflow and reducing exam time, Carestream’s DT technology is an upgradable option on the DRX-Evolution Plus System. This DT…

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Article • Robotic assistance for middle and inner ear procedures

Cochlear implant microsurgery progresses

Unlike other surgical specialties, ear nose and throat (ENT) has been poorly served by the introduction of robotic platforms to enhance procedures. Since the da Vinci system first gained FDA approval in 2000, robot-assisted surgery has become commonplace in many specialties, including neurology, urology, etc. with numerous other general surgical applications. However, existing systems including…

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News • New transfection approach

Immunotherapy: The 'FedEx and UPS equivalent of DNA delivery'

Immunotherapy is a promising cancer treatment that uses genetically modified immune cells to fight cancer. It can be used as a primary treatment or in combination with other treatments such as radiation and chemotherapy to slow down or stop the growth of cancer cells and prevent them from spreading to other parts of the body. Chimeric Antigen Receptor (CAR)-T cell therapy, for instance, is a…

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News • Rare lung disease

FDA approval for scleroderma treatment

The U.S. Food and Drug Administration approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition. “Patients suffering from scleroderma need effective therapies, and the FDA supports the efforts…

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News • Draft guidance

FDA: Include male breast cancer patients in trials

In its latest draft guidance, the U.S. Food and Drug Administration (FDA) encourages inclusion of males in breast cancer clinical trials. Historically, males either have not been included in clinical trials for drugs to treat breast cancer or inclusion of males in those trials has been very limited; when finalized, the draft guidance will provide clarity for industry regarding clinical…

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News • LITMUS vs NAFLD

Towards better diagnosis and treatment of liver disease

A pioneering European research project designed to develop new diagnostic tests to assess patients with Non-Alcoholic Fatty Liver Disease (NAFLD) has expanded giving access to more patients. Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS) funded by the European Innovative Medicines Initiative 2 Joint undertaking, brings together clinical scientists from international…

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News • Biocompatible alternative

Non-silicone breast implant to enter clinical trial

Surgery complications, implant rupture, tissue contractures or even plain immune intolerance – silicone breast implants can cause a variety of unfavourable conditions. Because of this, many women think twice about breast augmentation. A new kind of implant might change this up a bit. BellaSeno GmbH, a company developing absorbable implants using additive manufacturing technology, now announced…

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News • IT Solutions

Siemens Healthineers shows the power of data in the lab at AACC 2019

At the 71st AACC Annual Scientific Meeting & Clinical Lab Expo, Siemens Healthineers features in Booth #1039 its innovative IT solutions to combat the laboratory’s staffing challenges, limited budgets, and the increasing complexity in sample management and testing. “We will be demonstrating the power of our broad IT offerings and how the data they deliver, and artificial intelligence, can…

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News • Innovations for the clinic

Thermo Fisher Scientific showcases clinical lab equipment at AACC 2019

Thermo Fisher Scientific Inc. is showcasing its latest instruments, assays and software for improving speed, accuracy and usability across clinical and research labs during the 71st American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Laboratory Exposition (AACC 2019). Thermo Fisher is exhibiting in booth 2110 at the Anaheim Convention Center, Anaheim, Calif., August…

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Article • Revolution through AI

Pixel analysis: the new era of digital pathology

As reporting workload for pathology departments continues to rise rapidly, artificial Intelligence solutions are set to play an increasing role in daily practice. In many pathology departments the annual number of cases has risen by around 2-4% but the slides produced has doubled in the last decade. Histopathologist Professor David Snead identified this phenomenon within his own centre in the…

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News • Oncology

Anti-inflammation approach shows promise for preventing cancer metastasis

An anti-inflammatory drug called ketorolac, given before surgery, can promote long-term survival in animal models of cancer metastasis, a team of scientists has found. Furthermore, so-called "pro-resolution" therapies can also trigger the immune system to eliminate metastatic cells. The research also suggests that flanking chemotherapy with anti-inflammatory drugs can unleash anti-tumor…

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News • New at Science Park

OGT celebrates opening of new Cambridge site

Oxford Gene Technology (OGT), A Sysmex Group Company, has celebrated the opening of its new facility in Cambridge, UK. The opening ceremony, which took place at the company’s new premises on the prestigious Cambridge Science Park, was attended by the Department for International Trade (DIT) and local media as well as top-level representatives from OGT and its parent company, Sysmex Corporation.…

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News • Quality Assurance

A unique environment for cancer patient QA in proton therapy

IBA (Ion Beam Applications S.A.) announces the launch of myQA iON at the 2019 PTCOG conference. myQA iON significantly reduces the time needed for patient QA: The use of PT machine log files, process automation, task-based workflows, and the latest web technologies significantly increase QA efficiency while ensuring patient treatment safety. Compared to conventional detector measurements (at…

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Sponsored • Lab equipment

Citrine MS/MS – your Medical Diagnostic mass spectrometer

In the modern diagnostic lab, analytical challenges demand increased sensitivity, speed, robustness and reliability of any diagnostic system, and mass spectrometry is no different. Designed and manufactured with industry-leading technologies, Citrine meets these challenges head on, giving you confidence in your results and the best possible service to your patients. Citrine MS/MS from SCIEX…

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News • Transthyretin amyloid cardiomyopathy

New treatments for rare disease ATTR-CM approved

The U.S. Food and Drug Administration (FDA) approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable on a…

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News • Flow cytometry lab

New ClearLLab IVD Reagents launched

Beckman Coulter is launching the ClearLLab 10C System for the clinical flow cytometry lab. The new system is the first 10-color IVD panel of immunophenotyping reagents cleared by the Food and Drug Administration (FDA) for both lymphoid and myeloid lineages. The four dry pre-mixed antibody tubes use the company’s DURA Innovations technology, eliminating the need to pipette antibodies, improving…

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News • Total Laboratory Automation

TLA sets new standard for turnaround time

Beckman Coulter announced that the latest addition to its market-leading automation portfolio, the DxA 5000 total laboratory automation (TLA) solution has achieved European CE Mark and China Food and Drug Administration approval. In today’s healthcare environment, laboratories are highly focused on enhancing patient care by driving faster turnaround time, delivering quality results and…

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Article • Digital pathology & AI

Unleashing the power of digital pathology for precision medicine

Digital pathology, combined with the power of Artificial Intelligence (AI), is one of the most promising fields for the delivery of precision medicine. In the first keynote address for the 5th Digital Pathology & AI Congress (Europe) held in London last December, Professor of Pathology, Marilyn Bui, focused on how digital pathology is impacting on precision medicine. During her address,…

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News • New hematologic biomarker

FDA clearance for early sepsis indicator

A major milestone on its strategic mission to lead in sepsis diagnostics, Beckman Coulter announced that its Early Sepsis Indicator has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Sepsis is a global healthcare crisis that affects more than 30 million people worldwide. The Early Sepsis Indicator is a first-of-its-kind, hematology-based cellular biomarker that is…

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News • Personalized medicine

FDA approves first targeted therapy for metastatic bladder cancer

The U.S. Food and Drug Administration (FDA) granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. Patients should be selected for therapy with Balversa…

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News • Building a risk profile

Audiologists seek genetic link to tinnitus

Tinnitus, more commonly known as ringing in the ears, is a serious audiological and neurological condition affecting nearly 50 million Americans. Noise and music exposure are the predominant environmental risk factors for tinnitus. There is no known cure, and there are no FDA-approved medications developed specifically to treat it. The fact is, tinnitus is very common but not well understood. A…

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News • Rapid diagnostics

T2 Biosystems hosts integrated symposium at ECCMID 2019

T2 Biosystems, maker of rapid diagnostic technology to aid in the detection of blood stream infections to prevent sepsis, will host an integrated symposium titled “Rapid Diagnostics Direct from Whole Blood: A Solution for Fast and Appropriate Antimicrobial Therapy,” at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Amsterdam, Monday, April 15, 16:00-18:00…

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News • Breast healthcare

FDA advances landmark policy changes to modernize mammography services

The U.S. Food and Drug Administration (FDA) announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care. For the first time in more than 20 years of regulating mammography facilities, the agency is proposing amendments to key regulations that would help improve…

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News • Idiopathic pulmonary fibrosis

Protein linked to cancer growth drives deadly lung disease IPF

A protein associated with cancer growth appears to drive the deadly lung disease known as idiopathic pulmonary fibrosis (IPF), according to new research from Cedars-Sinai. The discovery, made in laboratory mice and human tissue samples, may have implications for treating the disease using existing anti-cancer therapies that inhibit the protein PD-L1. Idiopathic pulmonary fibrosis is a chronic,…

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News • Seeing red

Will nanotechnology give us infrared vision?

Mice with vision enhanced by nanotechnology were able to see infrared light as well as visible light, reports a study published in the journal Cell. A single injection of nanoparticles in the mice’s eyes bestowed infrared vision for up to 10 weeks with minimal side effects, allowing them to see infrared light even during the day and with enough specificity to distinguish between different…

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Article • Kickstarted imaging

First total body PET/CT scanner cleared for clinical use

The first total-body positron emission tomography/computed tomography (PET/CT) that can acquire a 3D image of the human body in a single position received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in January 2019. Its forthcoming commercial availability for clinical use in the United States later this year is the milestone achievement of a multi-institutional consortium…

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Article • Distributed learning

Radiomics on tap in 5-10 years

Keeping data within the hospital by sending the learning modules to each hospital database might prove a game-changer in radiomics, a leading Dutch researcher will show at ECR 2019. Radiomics, a field that aims to extract large amounts of quantitative features from medical images using data-characterisation algorithms, is a major advance for healthcare, according to Philippe Lambin, a radiation…

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News • Foodborne illnesses

Machine learning gets to the source of Salmonella

A team of scientists led by researchers at the University of Georgia Center for Food Safety in Griffin has developed a machine-learning approach that could lead to quicker identification of the animal source of certain Salmonella outbreaks. In the research, published in Emerging Infectious Diseases, Xiangyu Deng and his colleagues used more than a thousand genomes to predict the animal sources,…

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News • Gene therapy instead of anitibiotics

New treatment for Chlamydia discovered

Researchers at the University of Waterloo have developed a new way to prevent and treat Chlamydia, the most common sexually transmitted bacterial infection in the world. The new treatment differs from the traditional antibiotic treatment as it is a type of gene therapy that is delivered via nanotechnology and is showing a 65 per cent success rate in preventing chlamydia infection on a single…

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Article • Time for a revolution?

About the end of medicine, as we know it

Currently many researchers and experts assume that the next great socio-economic revolution will include a completely new definition of health and how we define illnesses and therapies. “Our health system today can no longer be sustained in its existing form. It has become too expensive and too ineffective,” Professor Harald Schmidt, head of the Department of Pharmacology and Personalised…

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News • Virtual reality

Glaucoma detection with brain-based VR device

A wearable brain-based device called NGoggle that incorporates virtual reality (VR) could help improve glaucoma diagnosis and prevent vision loss. Duke University researchers funded by the National Eye Institute (NEI) have launched a clinical study testing the device in hopes that it could decrease the burden of glaucoma, a major cause of blindness in the U.S. The device consists of head-mounted…

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News • Endoscopy RFA

New tool opens doors for pancreatic cancer treatment

A significantly more effective, minimally invasive treatment for pancreatic tumors may be on the horizon, thanks to a new endoscopy tool created in the Penn State Department of Mechanical Engineering. On average, only about 20 percent of pancreatic cancer patients are eligible for a surgical removal of the tumor, which is currently the most-effective treatment option. The location of the pancreas…

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Article • Getting personal(ised)

Pathology: Moving us towards precision medicine

The European Society of Pathology (ESP) holds its European Congress of Pathology (ECP) at different venues annually. This year, in Spain, 3,448 delegates from 87 countries attended. There, ESP president Dina Tiniakos spoke about the increasing role of pathology in precision medicine including challenges linked to digitisation. ‘Precision medicine is the centre-point for cancer management, but…

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News • Transcranial magnetic stimulation

Treating post-stroke depression with magnetic fields

Obstetricians and midwives often warn new mothers about postpartum depression. They might mention what symptoms women should look out for—such as crying spells or extreme irritability—and where they can turn for help. But people who have strokes may not learn that they, too, are at risk for depression. Post-stroke depression stems from the cardiovascular changes in the brain that lead to a…

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News • Neurology

Focused ultrasound: CE Mark for Exablate Neuro

Siemens Healthineers and Insightec announce the CE clearance of Exablate Neuro compatible with Magnetom Skyra, Prisma and Prisma Fit scanners from Siemens Healthineers. Exablate Neuro uses focused ultrasound for treatments deep within the brain with no surgical incisions. MR imaging provides a complete anatomical survey of the treatment area, patient-specific planning and real-time outcome…

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News • Less rejection

Citrate-based biomaterial fuels bone healing

A material based on a natural product of bones and citrus fruits, called citrate, provides the extra energy stem cells need to form new bone tissue, according to a team of Penn State bioengineers. The new understanding of the mechanism that allows citrate to aid in bone regeneration will help the researchers develop slow-release, biodegradable citrate-releasing scaffolds to act as bone-growth…

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Article • Evolving technique

Flow cytometry rises to new challenges

Flow cytometry has proved an invaluable diagnostic tool for leukaemia and lymphoma for almost three decades. Now, however, this is evolving in applications to seek out residual disease in cases and in fusion with molecular testing to advance its diagnostic potential. However, although recognised as fast, flexible and accurate, flow cytometry suffers from a lack of standardisation, according to…

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News • Emerging Tech

Will 3D printing bring radiology to the next level?

As 3D printing technology continues to evolve, read how radiology will be involved in managing digital workflow related to patient care. “3D printing is a part of medicine, and radiology is at the center of this impactful new technology,” said RSNA 3D Printing Special Interest Group (SIG) Chair Jane Matsumoto, MD, assistant professor of radiology and co-director of the 3D Printing Lab at the…

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Sponsored • Real walkaway automation

The all-in-one molecular laboratory system

The lab-in-the-box design of LabTurbo SP-qPCR All-in-one system offers true automation for the molecular laboratory, the manufacturer reports, adding that this ‘delivers testing confidence and laboratory efficiency. LabTurbo fully automates the complete workflow of molecular diagnostic laboratories. The sample-to-result procedure includes: automatic sample transfer from primary tubes, DNA/RNA…

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Sponsored • Handheld devices

The pocket-size lactate monitor

Made by EKF Diagnostics, the Lactate Scout 4 hand-held analyser is a fast, accurate sports performance monitoring device designed for use as a training companion for individuals or sports teams. This year at Medica the manufacturer is showing the new analyser plus many POC testing devices, including the recently FDA cleared DiaSpect Tm haemoglobin analyser and Quo-Lab® HbA1c analyser that was…

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Sponsored • Cardio app

AI system screens early Phase AFib

Here at Medica, the Taiwanese start-up Maisense is demonstrating Freescan, its artificial intelligence (AI) based solution to screen for stroke through the early detection of atrial fibrillation (AFib). Speaking of the system’s aims, Maisense summed up this huge health problem. ‘Every four minutes, someone dies of stroke. Thirteen percent of these are classified as haemorrhagic stroke. When…

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Video • Gene editing

The future of CRISPR in plastic and reconstructive surgery

The CRISPR genome editing technique promises to be a "transformative leap" in genetic engineering and therapy, affecting almost every area of medicine. That includes plastic surgery, with potential advances ranging from prevention of craniofacial malformations, to therapeutic skin grafts, to new types of rejection-free transplants, according to a paper in the November issue of Plastic…

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News • Tick-borne infection

New techniques detects Lyme disease weeks before current tests

Researchers have developed techniques to detect Lyme disease bacteria weeks sooner than current tests, allowing patients to start treatment earlier. The new techniques can detect an active infection with the Lyme bacteria faster than the three weeks it takes for the current indirect antibody-based tests, which have been a standard since 1994. Another advantage of the new tests is that a positive…

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Sponsored • Innovation

Hematology: Advancements and future trends

While the role of the laboratory in disease diagnosis and management has expanded in recent years, causing an overwhelming rise in testing demands, the availability of skilled technologists and specialists has been diminishing. To meet the needs of an overworked and increasingly generalized workforce, today’s products not only must deliver more clinical data than ever before, but also must be…

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Article • Cancer screening

What women should know about breast density

Breast density: it’s a topic that comes up often in the breast imaging industry and plays a crucial role in breast screening, as women with very dense breasts are four to five times more likely to develop breast cancer than women with less dense breasts. Additionally, the masking effect that breast density can have on an image, which can make it extremely challenging for radiologists to see and…

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News • Prostate cancer

Magnetic surgery takes promising first steps

Magnets may play a central role in the future of surgery. This summer, US surgeon Dr. Jeffrey Cadeddu performed the first of several magnet-assisted prostate cancer surgeries he has now done. “Every hole you create in a patient has a risk associated with it. Every incision means increased pain, increased risk of hitting a blood vessel,” days Dr. Cadeddu. The new magnetic approach might prove…

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News • Tech from Taiwan

Augmented reality is the future of surgery

Physicians have been performing surgery with the assistance of x-ray technology for almost half a century. While this technology has been progressing steadily, its limitations continue to be a major challenge. Thus, many professionals agree: it's time for our method to be changed. Taiwan Main Orthopaedics Biotechnology introduced the worldwide first smart surgical glasses.

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News • Reinforced learning

AI masters tightrope walk of cancer treatment dosage

Using a new approach called 'reinforced learning', researchers have taught an artificial intelligence (AI) to responsibly choose the right amount of chemo- and radiotherapy for glioblastoma patients. The technique, which is insprired by behavioural psychology, has given the AI the ability to master the tightrope walk between effective tumor shrinkage and the medications' severe side effects.

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News • Personalised drug treatment

AI approach to help myeloma patients

A multidisciplinary team of researchers from the National University of Singapore (NUS) has developed an artificial intelligence (AI) technology platform that could potentially change the way drug combinations are being designed, hence enabling doctors to determine the most effective drug combination for a patient quickly. Applying the platform towards drug resistant multiple myeloma, a type of…

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News • Quality assurance

Applying Monte Carlo accuracy with clinical workflow simplicity

IBA (Ion Beam Applications S.A.) announces the launch of SciMoCa, a new Monte Carlo-powered secondary dose check and plan verification software, at the 60th annual AAPM meeting. Monte Carlo is generally accepted as the gold standard for dose calculation accuracy in treatment planning. With SciMoCa, Monte Carlo accuracy is now available for secondary independent dose calculation and verification,…

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News • Acute myeloid leukaemia

Researchers draw AML ‘family trees’ in patients treated with enasidenib

For the first time, a team of international researchers have mapped the family trees of cancer cells in acute myeloid leukaemia (AML) to understand how this blood cancer responds to a new drug, enasidenib. The work also explains what happens when a patient stops responding to the treatment, providing important clues about how to combine enasidenib with other anti-cancer drugs to produce…

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Article • Heard at the EBCC11

Identifying circulating tumour cells with liquid biopsy

Liquid biopsies can increasingly help diagnose and monitor breast cancer, and tracking circulating tumour cells (CTC) in metastatic patients could prove effective in these applications and treatment planning. Efforts are currently underway to demonstrate CTC clinical use and much can be learned from completed studies in prostate cancer, speaker Michail Ignatiadis MD PhD highlighted in a dedicated…

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News • Surgical implant for damaged eyes

FDA approves first artificial iris

The U.S. Food and Drug Administration approved the first stand-alone prosthetic iris in the United States, a surgically implanted device to treat adults and children whose iris is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye. The iris is made of thin, foldable medical-grade silicone and is custom-sized and colored for each individual…

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News • New research

Circulating tumor cells to help stage metastatic breast cancer

Menarini Silicon Biosystems announced that a new study has found that using circulating tumor cells (CTCs), a form of liquid biopsy, holds promise as a key tool for developing a staging system that can have a significant impact in the treatment of metastatic breast cancer (MBC). In this study, the largest CTCs pooled analysis study to date, researchers determined that the CTC count could be used…

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News • ECCMID

Antibiotic combination against multidrug-resistant pathogens

Gram-negative pathogens are responsible for half of all healthcare-associated infections and their ability to resist traditional antibiotics makes them more dangerous for seriously ill patients in a healthcare setting. The need for new approaches to treat these pathogens is essential and there are a number of trials trying to find suitable answers. One of them is the RESTORE-IMI 1 pivotal Phase…

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News • Idiopathic pulmonary fibrosis

The most dangerous lung disease you've never heard of

Idiopathic pulmonary fibrosis (IPF) is one of the most challenging and frustrating diseases that pulmonologists face. And despite affecting 1 out of 200 adults over the age of 65 in the United States, general awareness of IPF is low. “There’s a tremendous disconnect between the human impact of this disease and its recognition by the public. Few people have ever heard of it,” says Marc…

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News • Bone health

Osteoporosis defined: causes, symptoms and treatments

Weak, easily broken bones are an epidemic in the United States. They’re often tied to osteoporosis, a disease that causes bones to degenerate over time. This makes them less flexible, more brittle, and easier to break. According to the International Osteoporosis Foundation, more than 44 million Americans aged 50 and older either have or face the threat of developing osteoporosis due to low bone…

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News • Pivotal trial

Parkinson's disease: First patient treated with focused ultrasound

The first patient in a multicenter pivotal trial using focused ultrasound to address the major motor symptoms of Parkinson’s disease has been treated at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center in New York. This randomized, double-blind clinical trial is evaluating the safety and efficacy of using Insightec’s Exablate Neuro device in more than 100 patients…

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News • New report

Advanced development of primary pancreatic organoid tumor models for high-throughput phenotypic drug screening

A multidisciplinary team of scientists share recent advancements in innovative in-vitro cancer biology methods for screening drug-like molecules in cancer tissue relevant models in a new report published online ahead-of-print at SLAS Discovery. Entitled Advanced Development of Primary Pancreatic Organoid Tumor Models for High-Throughput Phenotypic Drug Screening, the report can be accessed for…

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News • Immunotherapy

Promising vaccine suppresses peanut allergies in mice

A vaccine may successfully turn off peanut allergy in mice, a new study shows. Just three monthly doses of a nasal vaccine protected the mice from allergic reactions upon exposure to peanut, according to research from the Mary H. Weiser Food Allergy Center at the University of Michigan. The study, funded by grants from Food Allergy Research and Education (FARE) and the Department of Defense, was…

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News • New FDA info

Can breast implants increase lymphoma risk?

The FDA has been closely tracking the relationship between breast implants and a rare type of non-Hodgkin's lymphoma since we first identified this possible association. We’ve been working to gather additional information to better characterize and quantify the risk so that patients and providers can have more informed discussions about breast implants,” said Binita Ashar, M.D., director of…

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News • Anti-rejection medicine

Drugs used after organ transplant could protect against Alzheimer’s

A UT Southwestern study in mice provides new clues about how a class of anti-rejection drugs used after organ transplants may also slow the progression of early-stage Alzheimer’s disease. Alzheimer’s, a progressive form of dementia, affects an estimated 5 million people in the U.S. – a number expected to nearly triple by 2050. Although Alzheimer’s usually strikes after age 65, changes in…

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News • Global partnership

Philips and Hologic team up for women’s health

Royal Philips, a global leader in health technology, and Hologic, Inc., an innovative women’s health company, announced a global partnership agreement to offer care professionals integrated solutions comprising diagnostic imaging modalities, advanced informatics and services for screening, diagnosis and treatment of women across the world. The collaboration combines Hologic’s innovative…

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Article • Healthcare artificial intelligence

AI – Radiology’s next frontier

Artificial intelligence (AI) technology and its role and future impact on the radiology profession was the dominant theme at RSNA 2017, whether in scientific presentations or in the technical exhibitions. Keith J Dreyer DO PhD addressed this subject head-on in his presentation ‘Healthcare AI – Radiology’s Next Frontier.’ Dr Keith Dreyer, vice chairman of radiology informatics and chief…

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Article • In the brain

Gadolinium deposition: A real threat or a phantom debate?

The European Medicines Agency (EMA) decided to suspend authorisation for certain linear gadolinium agents. The review by the Committee for Medicinal Products for Human Use (CHMP) states: “There is currently no evidence that gadolinium deposition in the brain has caused any harm to patients; however EMA has recommended restrictions and suspensions for some intravenous linear agents in order to…

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Article • Tomosynthesis

Catching more invasive cancers earlier

What beats digital mammography to detect breast cancer in asymptomatic women? Digital breast tomosynthesis (DBT) – was a big discussion at RSNA 2017. Sarah M Friedewald MD, medical director of the Lynn Sage Comprehensive Breast Center of Northwestern Memorial Hospital in Chicago and its division chief of breast and women’s imaging, discussed the clinical implications of DBT for routine…

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Article • Therapy monitoring

Liquid biopsy versus radiomics – the race is on

The development of new procedures to monitor cancer treatments is gathering momentum. One such innovation is liquid biopsy. This new lab technique allows non-invasive identification, characterisation and monitoring of circulating tumour DNA. Thus, liquid biopsy can potentially revolutionise oncological diagnostics – and put a spoke in the wheel of radiology. High time to act, says Professor Dr…

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Article • Initiative

Knowledge dissemination key to defeating cancer?

Half of cancers can be avoided if institutions would exchange knowledge, according to Joxel García, executive director of the University of Texas MD Anderson Cancer Center in Houston, who opened the Center’s meeting in Madrid in October 2016. Technology has progressed enormously and there has never been that much knowledge of cancer to prevent it and find treatment tools.

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Article • Diverse benefits

Experts present CEUS insights

In April 2016 CEUS received the USA’s FDA approval. This year‘s RSNA Samsung Symposium ‘Contrast-Enhanced Ultrasound (CEUS): Innovations and a Problem-Solving Tool in Clinical Practice’ provided an opportunity to take stock. For European Hospital, Professor André Clevert, Director of the Interdisciplinary Centre for Ultrasound at University Hospital Munich, Germany, describes the current…

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News • Clinical diagnostics

SCIEX launches high-performance mass spectrometry technology

SCIEX Diagnostics, the in vitro diagnostics division of SCIEX, a global leader in mass spectrometry in the life sciences industry, announced the launch of the Citrine Triple Quad MS/MS and Citrine QTRAP MS/MS systems for clinical diagnostics. The Citrine system is designed specifically to meet the unique needs of clinical labs that require maximum sensitivity, the highest throughput, a wide…

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News • Cancer research

Bioengineered soft microfibers improve T-cell production

T cells play a key role in the body’s immune response against pathogens. As a new class of therapeutic approaches, T cells are being harnessed to fight cancer, promising more precise, longer-lasting mitigation than traditional, chemical-based approaches. These “living drugs” are poised to transform medicine, with a growing number of cellular therapies receiving FDA-approval. A current…

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News • Power up your brain

Exercising may improve thinking ability and memory

Exercising twice a week may improve thinking ability and memory in people with mild cognitive impairment (MCI), according to a guideline released by the American Academy of Neurology. The recommendation is an update to the AAN’s previous guideline on mild cognitive impairment and is published in the online issue of Neurology, the medical journal of the American Academy of Neurology. The…

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Article • TAITRA presentation

Taipei hits highs in Medica 2017

3-D visualisation, augmented reality, automated tumour classification – today, the Republic of China produces cutting-edge medical technology and it’s a long time since ‘Made in Taiwan’ stood for inferior, copied products. Over recent years, this island state has successfully morphed into a productive and, above all, innovative manufacturer of medical technology available on the world…

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News • Share information, improve care

FDA launches new tool for improved antibiotic management

The U.S. Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug.…

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News • Cooperation

GE and NVIDIA join forces to accelerate AI adoption in healthcare

GE Healthcare and NVIDIA announced they will deepen their 10-year partnership to bring the most sophisticated artificial intelligence (AI) to GE Healthcare’s 500,000 imaging devices globally and accelerate the speed at which healthcare data can be processed. The scope of the partnership, detailed at the 103rd annual meeting of the Radiological Society of North America (RSNA), includes the…

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News • Introducing

Samsung unveils new innovative mobile CT OmniTom at RSNA

Samsung Electronics, a leader in medical imaging technology, will debut its OmniTom mobile 16-slice computed tomography (CT) scanner at the Radiological Society of North America (RSNA) 2017 Annual Meeting at McCormick Place in Chicago. OmniTom received 510(k) FDA clearance for the U.S. market on August 18 of this year, and attendees will get to see it for the first time at RSNA booth #2543 (South…

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News • New study

Prostate Health Index drastically cuts down biopsy rate

A study published in Prostate Cancer and Prostatic Diseases demonstrated that physicians elected to perform fewer biopsies when Prostate Health Index (phi) testing was included in their overall, routine, clinical assessment. Phi testing is recommended for men presenting with elevated serum total prostate-specific antigen (PSA) in the 4-10 ng/mL range and a non-suspicious digital rectal exam…

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News • Bleak prediction

Breast cancer treatment costs to strain medicare in the near future

With cancer care costs projected to increase 32% from 2010 to 2020, researchers are working to determine the main drivers of costs for treating breast cancer. Breast cancer accounted for the highest proportion (13%) of the $124.6 billion in Medicare money spent on cancer care in 2010. In a study led by Ami Vyas, PhD, MS, MBA (currently at the University of Rhode Island) and published in the…

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Sponsored • Non-invasive sensors

Manometry v. BioBeat

A preliminary human study was conducted to validate an advanced wearable sensor which has been developed by the start-up company BioBeat Technologies Ltd, comparing it to the common manometry method. The 2015 guidelines of the European Society of Hypertension on The requirements of the International Protocol (revision 2010) were used to define the difference between the commonly used device and…

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Article • The all-in-one portable telemedicine station

Small, smart and mobile

‘Visiomed, a French leader in medical grade connected devices and services that advocate patient engagement as a primary component to maintaining good health, is proud to launch VisioCheck BW-XO7HD – the first scalable and connected mobile and evolving telemedicine station that weighs under 10.5 ounces,’ the company reports.

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News • Research discovery

New blood test may diagnose breast cancer

In a potential major breakthrough in breast cancer research, scientists at the Center for Translational Cancer Research (CTCR) at the Helen F. Graham Cancer Center & Research Institute of Christiana Care Health System have developed a revolutionary new blood test to diagnose breast cancer.

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News • Celebration & demonstration

Agfa HealthCare anniversary at RSNA 2017

Agfa HealthCare celebrates 150 years of expertise and innovation at RSNA 2017, showcasing its contemporary solutions' direct impact on productivity and costs. Demonstrations of "Care You Can See" include highlighting the company's signature integrated platform approach to elevate medical imaging as network-wide assets throughout the continuum of care.

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Article • Electrospinning

Renewing the promise of bioabsorbable implants

Electrospun materials bring a spark of hope to a cardiovascular landscape darkened by setbacks for reabsorbable stents. It was famously said that implanting a device in a person to cure a disease is to implant a new disease. Simply put, the human body will continually fight against foreign materials, leading to chronic inflammations or repeated interventions.

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Article • Hygiene guidelines

Hand washing: in hot or cold water?

‘The literature on hand washing, while extensive, often contains conflicting data, and key variables are only superficially studied, or not studied at all. Some hand washing recommendations are made without scientific support, and agreement between recommendations is limited,’ explained Professor Donald W Schaffner at Rutgers University, New Jersey, USA, who has led a team of researchers to…

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News • Mass spectrometry

SCIEX announces first FDA-cleared Vitamin D assay kit

SCIEX Diagnostics, the in vitro diagnostics division of SCIEX, a global leader in mass spectrometry in the life sciences industry, announced the first and only FDA-cleared (via the de novo pathway) LC-MS based Vitamin D assay kit, the Vitamin D 200M Assay, exclusively for the SCIEX Topaz System. The Topaz System is a fully integrated LC-MS platform driven by ClearCore MD, the new and intuitive…

News • Laboratory

Partnership for molecular diagnostic test

SpeeDx Pty. Ltd., a developer of innovative molecular diagnostic solutions, has signed an agreement with Thermo Fisher Scientific, the world leader in serving science. The announcement was made at the 27th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) in Vienna to submit its ResistancePlus MG Test for the detection of Mycoplasma genitalium to the US Food & Drug…

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News • blood bank refrigerators

Thermo Fisher Scientific Earns First U.S. EPA ENERGY STAR Certification

Clinicians working across blood banking and transfusion applications can now reduce the environmental footprint of their operations by selecting certified energy-efficient refrigerators that have received a U.S. Environmental Protection Agency (EPA) ENERGY STAR label.

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News • Telepathology

Sectra to implement unique nationwide telepathology solution in the Netherlands

International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has signed a contract with the organization Pathology Projects (SPP) in the Netherlands to offer all 50 pathology labs in the country to connect to a shared telepathology solution. Sectra’s cloud-based image-sharing solution will enable pathologists to efficiently share digital pathology images on a national scale.…

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Article • Innovation

A swift new lab automation system

‘Every single hour, more than 200,000 people worldwide are being diagnosed or treated with our devices,’ Michael Reitermann, COO of Siemens Healthineers, proudly reports. No reason, however, for Siemens to rest on its laurels. Quite the contrary: the company continues to drive innovation.

News • iCAGES

New precision medicine tool helps optimize cancer treatment

Columbia University Medical Center (CUMC) researchers have created a computational tool that can rapidly predict which genes are implicated in an individual’s cancer and recommend treatments. It is among the most comprehensive tools of its kind, and the first that incorporates a user-friendly web interface that requires little knowledge of bioinformatics.

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News • Automation

Faster liquid handling system development for OEM applications

Tecan is making it quicker and easier than ever before for manufacturers to develop instruments for advanced liquid handling applications. The launch of the new Cavro Omni Flex further extends the flexibility and convenience of the company’s popular Cavro Omni Robot by offering more hardware options to complement its precision pipetting, including frames, worktables, power and input/output…

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Article • Computerised blood bank

An integrated single database solution

According to a 2007 World Health Organization report*, patient misidentification was cited in more than 100 individual root cause analyses (January 2000 to March 2003) by the USA’s Department of Veterans Affairs National Centre for Patient Safety. Major areas where patient misidentification can occur include drug administration, phlebotomy, blood transfusion, and surgical procedures.

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News • High-resolution CT

Frost & Sullivan awards Carestream top Honors for OnSight 3D Extremity System

Based on its recent analysis of the CT market for extremity imaging, Frost & Sullivan recognizes Carestream Health with the 2016 North American Frost & Sullivan Award for New Product Innovation. Carestream's FDA-approved cone beam computerized tomography (CBCT) device, the OnSight 3D Extremity System, is proving to be a game-changer with its ergonomic design and unparalleled features.…

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Artificial blood vessels can grow with the recipient

In a groundbreaking new study led by University of Minnesota biomedical engineers, artificial blood vessels bioengineered in the lab and implanted in young lambs are capable of growth within the recipient. If confirmed in humans, these new vessel grafts would prevent the need for repeated surgeries in some children with congenital heart defects.

News • Market

Curetis Acquires Rights to GEAR Database

Curetis announced the signing of an asset acquisition agreement with the Siemens Technology Accelerator GmbH (STA). Under the terms of the agreement, Curetis has acquired sole commercial rights from STA to the GEAR GEnetic Antibiotic Resistance and Susceptibility platform and database with all its content, numerous GEAR-related patents and patent applications, as well as all corresponding…

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News • Noninvasive

Tremor: scalpel-free surgery proves effective

A study published in the prestigious New England Journal of Medicine offers the most in-depth assessment yet of the safety and effectiveness of a high-tech alternative to brain surgery to treat the uncontrollable shaking caused by the most common movement disorder. And the news is very good.

News • Agreement

Siemens and INSIGHTEC provide access to Exablate Neuro technology

INSIGHTEC announced the signing of a strategic agreement with the global leader in Magnetic Resonance Imaging, Siemens Healthineers. The strategic collaboration will involve the development of compatibility between Exablate Neuro and Siemens leading 1.5T and 3T clinical MRI systems, MAGNETOM Aera and Skyra. With this agreement, Siemens Healthineers follows its strategy of broadening and…

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News • Infection

Siemens Zika test receives FDA emergency use authorization

The U.S. Food and Drug Administration (FDA) has granted Siemens Healthcare Diagnostics Inc. (Siemens) an Emergency Use Authorization (EUA) for its real-time PCR Zika Virus assay, the VERSANT® Zika RNA 1.0 Assay (kPCR) Kit. With respect to Zika in vitro diagnostic tests, FDA has been authorized to issue EUAs to allow for use of unapproved medical products or unapproved uses of approved medical…

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News • Micra TPS

The world’s smallest pacemaker

Jersey Shore University Medical Center, part of Meridian CardioVascular Network, is the first hospital in New Jersey to implant the Micra® Transcatheter Pacing System (TPS) – the world’s smallest pacemaker – since the device gained U.S. Food and Drug Administration (FDA) approval in April 2016.

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News • Brain disorder

Using ultrasound to achieve permeability of blood vessels

CarThera, a French company based at the Brain and Spine Institute (ICM), that designs and develops innovative ultrasound-based medical devices to treat brain disorders, announces the publication on initial successes in disrupting the blood-brain barrier (BBB) with the use of ultrasound. This has been achieved in association with teams from the Assistance Publique-Hôpitaux de Paris (the Greater…

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News • Regenerated Bone

Living bone replicates original anatomical structure

A new technique developed by Gordana Vunjak-Novakovic, the Mikati Foundation Professor of Biomedical Engineering at Columbia Engineering and professor of medical sciences (in Medicine) at Columbia University, repairs large bone defects in the head and face by using lab-grown living bone, tailored to the patient and the defect being treated. This is the first time researchers have grown living…

News • Politics

Liquid biopsy test from Roche gets FDA approval

The U.S. Food and Drug Administration approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell…

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Article • OnSight 3D Extremity System

Carestream Submits Application for FDA 510(k) Clearance

Carestream Health has filed a 510(k) application with the FDA for clearance of its CARESTREAM OnSight 3D Extremity System that uses cone beam CT (CBCT) technology to capture weight-bearing and other types of patient extremity images. This affordable system is designed to offer high-quality, low-dose 3D imaging for use by orthopaedic and sports medicine practices, hospitals, imaging centers,…

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Article • Obesity

Bariatric arterial embolisation

Radiology is going beyond assessing body fat, bringing a notable contribution in weight loss therapy. Clifford Weiss from Johns Hopkins University is one of the pioneers of a new procedure, bariatric arterial embolisation, details of which he will unveil at the ECR 2016.

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Article • Politics

EU aims to avoid opioid epidemic

In the USA, there is already talk of an ‘opioid epidemic’. Whereas in the past 20 years some 100,000 people died directly or indirectly through prescribed opioids, reports indicate that more than 16,000 died in 2010 alone. Since the sales of opioid analgesics quadrupled between 1999 and 2010 recent debates have intensified surrounding the use of opioids for non-tumour-related pain in the USA,…

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News • VenomKB

World's first therapeutic venom database

What doesn't kill you could cure you. A growing interest in the therapeutic value of animal venom has led a pair of Columbia University data scientists to create the first catalog of known animal toxins and their physiological effects on humans.

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News • Health 2.0

SonoSite announced iViz Portable Ultrasound Device Integration

Trice Imaging announced today at Health 2.0 the integration of Tricefy into FUJIFILM SonoSite’s latest portable ultrasound device. The iViz, which was recently CE marked for sale in Europe and currently pending FDA 510(k) clearance, is the latest point-of-care visualization solution by FUJIFILM SonoSite and includes Trice sharing, collaboration and routing software embedded in the device. Both…

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Interview • Genom

I looked into my genes and changed some habits

“These dates we have access to a lot of genetic information which had previously not been available to us. For the individual, this can provide options for action with regards to leading a healthier lifestyle or to try and prevent diseases,” knows Dr. Theodor Dingermann. The senior professor of the Goethe University in Frankfurt am Main has had his own genome decoded. In parts, the result…

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News • Cancer care

Swedish healthcare region invests in digital pathology from Sectra

The Swedish healthcare Region Östergötland is making a full commitment to digital pathology by investing in a solution from Sectra for storage, review and sharing of digital pathology images. The aim of the region’s investment is more rapid care for cancer patients, in which pathology has a key role in diagnosis and treatment.

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News • Lung cancer

Immunotherapy superior to chemotherapy?

Researchers compared an immunotherapy and a chemotherapy drug in patients with non-squamous non-small cell lung cancer (NSCLC) whose disease continued to progress after first-line chemotherapy. They found that nivolumab improved overall survival and was generally well tolerated. The results are significant because options for patients whose lung cancer progresses after initial treatment are…

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Article • Politics

Spain’s response to EU directive

Increasingly resistant bacteria are a global problem and require innovative action from all parties concerned, says Jesús Rodriguez-Baño, President of the Scientific Committee of the annual meeting of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), which unfolded last May in Seville. EH asked him why the creation of a national plan has become necessary to tackle…

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Article • Lab2Go

POC test detects myocardial infarction

Philips Minicare delivers rule-in/rule-out readings for heart attacks in 10 minutes. It takes a lot of hard work to make things easy. Biomedical experts at Royal Philips have spent more than 10 years developing a simple test for the emergency department that, in less than 10 minutes, may indicate whether a patient suffering chest pains is having a heart attack.

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News • Swiss Army Knife for Laboratories

Liquid Chromatography Tandem Mass Spectrometry

During the past 15 years, liquid chromatography tandem mass spectrometry (LC-MS/MS) has evolved into a vital technology used to perform routine tests in many clinical laboratories. Historically, LC-MS/MS had been used primarily by research, pharmaceutical, or commercial laboratories; however, advances in the technology, decreasing costs for basic systems, intelligible software, an increased…

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News • Investment

Carestream showcases new technologies

Carestream is expanding into new imaging modalities: cone beam CT and ultrasound. Key advances in these areas will be demonstrated at the upcoming Association for Medical Imaging Management (AHRA) conference on July 19-22. For cone beam CT which is currently undergoing patient studies, a conceptual scale model will be on display.

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Article • Infectious diseases

Carrying home a nosocomial infection

About 6-8% of Spanish patients will develop an infection during or after a hospital stay. Can these infections be avoided? How is Spain facing up to the challenge? Dr Juan Pablo Horcajada, Head of the Department of Infectious Diseases at Hospital del Mar, Barcelona, and spokesperson of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), assessed the situation and…

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News • Proteomics International Laboratories Ltd.

Predictive test for diagnosis of diabetic kidney disease

Life sciences company Proteomics International Laboratories (ASX: PIQ) is pleased to announce that it has produced and validated a predictive test for the diagnosis of diabetic kidney disease (DKD). The test, called PromarkerD, is the world's first proteomics-derived predictive (prognostic) test for the diagnosis of DKD, and represents a global breakthrough in the diagnosis and treatment of the…

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Article • Orthopedics

Bioactive gel to treat knee injuries

Knee injuries are the bane of athletes everywhere, from professionals and college stars to weekend warriors. Current surgical options for repairing damaged cartilage caused by knee injuries are costly, can have complications, and often are not very effective in the long run. Even after surgery, cartilage degeneration can progress leading to painful arthritis. But a University of Iowa orthopedics…

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News • ECCMID 2015

Curetis launches next-generation pneumonia application

Curetis AG, a developer of next-level molecular diagnostic solutions, announced the successful completion of the clinical and analytical CE performance evaluation of its next-generation Unyvero P55 Pneumonia Application. The upgraded cartridge will launch at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID, April 25 – 28, 2015 in Copenhagen, Denmark) and is…

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Article • Infection Control

POCT accelerates diagnosis of STDs

Trichomonias, with an estimated 187 million cases, and Chlamydia with around 100 million, are the most prevalent sexually transmitted diseases (STDs), according to the World Health Organisation (WHO). There are approximately 36 million cases each of gonorrhoea and syphilis. HIV1/2 cases are around 34 million. Report: Cynthia Keen

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Article • Technology

Virtual assistance during procedures

The adage ‘practice makes perfect’ is applicable to every profession – but even more so for pilots and surgeons. Flight simulation technology has been used for decades to hone aviators’ skills, and this technology is now being used by neurosurgeons to plan as well as practise surgical procedures and for real-time virtual assistance in operating theatre. Report: Cynthia E Keen

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Article • CT Imaging

Wake-up call for European stakeholders: CT lung cancer screening approved by CMS

The U.S. Centers for Medicare and Medicaid Services (CMS) have approved CT lung cancer screening for high-risk individuals. This decision clears the implementation path of screening for the general public. Solutions supporting imaging centers in this complex process are showcased at RSNA 2014.

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Article • CT Imaging

Fast, safe, and convenient

RSNA 2014: With lung screening approved by the CMS and endorsed by the USPSTF, MeVis Medical Solutions AG helps imaging centres handle the vast number of clients: Veolity, a reading platform for high-throughput environments, supports radiologies in ensuring diagnostic precision and safeguarding adherence to guidelines.

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US trails Europe in facilitating novel antibiotics development

While the Generating Antibiotic Incentives Now (GAIN) Act of 2012 has been a significant step in the right direction for encouraging novel antibiotics research, the US Food and Drug Administration (FDA) remains one step behind its European equivalent, the European Medicines Agency (EMA), according to an analyst with research and consulting firm GlobalData.

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Oocyte modification

USA - Oocyte modification to eliminate inherited mitochondrial defects in a human embryo was the subject of a globally scrutinised Food and Drug Administration (FDA) hearing held in February.

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Article • Clinical chemistry

THE AACC FORUM 2014

This April, in San Jose, California, the portable lab took central stage at the American Association for Clinical Chemistry’s (AACC) annual forum for emerging clinical diagnostic technologies – a most appropriate topic for the Silicon Valley venue where so many world-changing computer and communications innovations have been born.

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Article • Mobile

MRI goes wireless

The current setup for MRI-guided interventions is challenging. With a physician positioned in the MRI room and an MRI operator in an adjacent room, setting scanning parameters requires communication by hand signals or via a headset that comes with inconvenient cabling.

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Responses to six misperceptions

Ageing populations, struggling healthcare systems, medical staff shortages, rising costs – all are well recognised. Thus telemedicine, dubbed the ‘gold rush of the 21st century’ earlier in the year by Jonathan D Linkous, CEO of the American Telemedicine Association (ATA), is gaining momentum.

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The fall and rise of cardiac surgery innovations

Grandly announced, the da Vinci became the must-have of any self-respecting cardiac surgeon, only to sink into obscurity as quickly as it had risen to stardom. Once the wunderkind of robotic surgery, today this surgical system is merely collecting dust on many a hospital cupboard. A whole slew of methods and technologies were launched with varied fanfares over the past ten years. European…

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China looks inward and outward

From the meetings between the Presidents of China and the USA came the slogan, ‘A new model of cooperation’. One item discussed was the proposed $4.6 billion purchase of a US pork producer by a Chinese company, which affirmed: ‘the acquisition won’t affect the quality of the bacon on stateside breakfast tables’.

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Gastein 2013 on resilience and innovation

‘How can we make European healthcare systems resilient against crises and still remain innovative?’ asks Professor Helmut Brand, President of the European Health Forum Gastein (EHFG), highlighting the core issues of this year’s agenda of the renowned event (2-4 October).

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Digital pathology

Although evolving as a tool in medical pathology for years, several factors have hampered its widespread use in this field. Now, a Scientific American article asserts that the time has come for a digital imaging revolution.

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MRI powerhouse breaks new ground in medical research

At RSNA 2012, Siemens is launching its new MRI addressing academic research centres and university hospitals. According to Bernd Ohnesorge, the Magnetom Prisma 3.0 T enforces the company’s major commitment to advancing research, bearing testimony to Siemens’ innovation leadership in the field. In Chicago, the CEO of the Siemens MRI business unit presented the 3 T system for which the company…

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European certification for medical products

The recent scandal around faulty breast implants from France started it, first the talk about the entire medical devices industry, and then progression towards the monitoring and licensing of products. Report: Brigitte Dinkloh

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Agfa launches DX-D 600 at RSNA 2011

Agfa HealthCare announces that it will launch its automated DX-D 600 direct radiography (DR) system, which has received 510k clearance by the U.S. FDA, into the U.S. market at RSNA 2011. Combining user-friendly design with excellent image quality in a high-productivity direct digital X-ray room, the fully automatic system also offers the latest in state-of-the-art auto-positioning technology.

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Mobility IT

Medical notepads will soon be a thing of the past in doctors' offices and hospitals. More and more medical applications for smartphones and tablet PCs are coming onto the market, and many of them are introduced at Düsseldorf's MEDICA

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Papworth Hospital: A constant continuing success

Recent events have again underlined the reason why Papworth Hospital in ambridgeshire, England, maintains a enowned international reputation for cardiac and thoracic procedures. As Britains largest specialist cardiothoracic hospitals, over 2,000 major heart operations were performed there in 2010. In the year ending 1 April 2011, 824 patients had coronary bypass operations, including urgent,…

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Four automated immunosuppressant drug tests on one integrated system

Following CE mark registration to sell a fully-automated Mycophenolic acid (MPAT) test for use on the Dimension integrated chemistry systems*, Siemens Healthcare Diagnostics has become the first to offer the consolidation of four fully-automated immunosuppressant drug (ISD) tests -- Mycophenolic acid, Cyclosporine, Tacrolimus and Sirolimus – used to monitor organ transplant patients.

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Hologic Selenia receives EUREF certification

Hologic announced today that its Selenia Dimensions digital mammography system in two dimensional (2D) mode has been awarded “EUREF Type Test” certification by the European Reference Organization (EUREF) Council for Quality Assured Breast Screening and Diagnostic Services.

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Easy breathe - new tools for prolonged lung support

Often a life-saving intervention, mechanical ventilation also has some serious drawbacks: the need for sedation, the risk of ventilator associated pneumonia, intubation or tracheostomy related complications. In 1972, Donald Hill from Pacific Medical Centre, Los Angeles, reported the first successful long-term mechanical lung assist device with extracorporeal membrane oxygenation (ECMO).

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Reading tissues

The trend towards personalised medicine implies the development of targeted cancer therapy. Tissue based examinations by pathologists play a key role in this trend. However, the relevance is still underestimated as pathologist Professor Manfred Dietel noted in his lecture at the European Forum on Oncology 2010 in Berlin, which explained what pathology already actually renders to targeted cancer…

Article • Reading tissues

Pathologists enable targeted cancer therapy

The trend towards personalised medicine implies the development of targeted cancer therapy. Tissue based examinations by pathologists play a key role in this trend. However, the relevance is still underestimated as pathologist Professor Manfred Dietel noted in his lecture at the European Forum on Oncology 2010 in Berlin, which explained what pathology already actually renders to targeted cancer…

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Ingenia, the first-ever digital broadband MRI system

At the 96th annual meeting of the Radiological Society of North America (RSNA) in Chicago, Philips showcased Philips Ingenia, the first-ever digital broadband magnetic resonance imaging (MRI) solution. Driven by Philips’ commitment to developing innovative patient care solutions, Ingenia MR delivers exceptional image clarity, scanning efficiency and scalability. The Philips Ingenia MR system is…

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RSNA 2010 Refresher course: A focus on major contrast agent issues

The 90-minute refresher course ‘Contrast Agent Issues 2010: What the Experts Really Do for Allergies, Contrast-induced Nephropathy, Nephrogenic Systemic Fibrosis, and Extravasation’, to be held during this year’s Radiological Society of North America meeting, will focus on the use of iodinated and gadolinium-based contrast media and the issues, advantages and considerations for patient…

The notable risks in the use of bone cement

Used in numerous orthopaedic medical procedures, PMMA is a self-curing two component system that includes liquid and powder components. The liquid is methylmethacrylate monomer, a known deadly toxin, and PMMA toxicity is well documented in medical journals and regulatory publications. After many years of reported patient issues related to PMMA, doctors began calling these surgical complications…

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Arteries seen in a new light

New imaging technologies are opening a new chapter in interventional cardiology by offering something this widely practiced procedure has been missing -- vivid clinical evidence to assess effectiveness. Interventional cardiology has moved rapidly from opening blocked arteries by crushing plaque with inflatable balloons to reinforcing the walls of the re-opened arteries with flexible metal stents…

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The ultra-high-field MRI symposium

Early problems of ultra-high field Magnetic Resonance Imaging (MRI) have been overcome by successful development of adequate hardware. In consequence big efforts have been achieved in structural imaging, as well in functional imaging. Basic scientists and physicians who work in ultra-high-field MRI in Europe and the USA, met at the Berlin Ultra-high-field Facility (BUFF), in the Max Dehlbrück…

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Insulin without patent protection

A new method to produce insulin cheaply has been developed by researchers at the Helmholtz-Centre for Infection Research (HZI) in Braunschweig, in a German-Indo collaboration. The group’s results are published in the open access online research magazine Microbial Cell Factories. The data is freely accessible by anyone and is not subject to patent law.

GE Healthcare at Euroanaesthesia

Clinicians all over the world use GE Healthcare products and solutions to anesthetize patients. The breakthrough ideas of a small Ohio company in 1910, the predecessor to the anesthesia division of GE Healthcare, have evolved into innovations that continue to open new frontiers in anesthesia. Today, GE Healthcare provides anesthesia technologies in many countries worldwide, collaborating closely…

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Video: First whole-body MRI in Europe

Something that often obstructs a pioneering medical spirit is simply a practicality: the lack of space. For many hospitals, investment in new medical equipment is linked with construction and reshaping the hospital’s architecture – sometimes impossible because of the infrastructure. This was precisely the situation at the University Hospital Geneva (Hôpitaux Universitaires de Genève = HUG)…

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The diagnostic laptop

Toshiba America Medical Systems, Inc.’ reports that its new Viamo laptop device is ‘…the industry’s no-compromise ultrasound system with advanced radiology capabilities, previously unavailable on hand-carried systems’, adding that It offers the same premier image quality as larger, more expensive ultrasound systems, but at a lower price.

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Ultrasound device in pocket size

GE Healthcare presented Vscan, a new, pocket-sized visualization tool developed to provide physicians with imaging capabilities at the point-of-care. Roughly the size of a smart phone, Vscan houses powerful, ultra-smart ultrasound technology that provides clinicians with an immediate, non-invasive method to help secure visual information about what is happening inside the body. Vscan is portable…

Laptop ultrasound system receives FDA clearance

Designed to meet the needs of today’s hospitals by combining portability with high-end radiology features, Toshiba America Medical Systems, Inc.’s new Viamo laptop ultrasound system has received FDA clearance. The Viamo is the industry’s no-compromise ultrasound system with advanced radiology capabilities, previously unavailable on hand-carried systems. Toshiba’s Viamo provides the best…

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The USB health card

Entrepreneur Dr Gunter Pollanz was a central figure in the build-up of charter flights to Israel and in the foundation of MAOF Airlines in Tel Aviv. Later, he also developed important export structures from Israel to Europe. However, in 1997 his life took a dramatic turn when he was diagnosed with lymphoma. Prognosis: Although 54 years old he faced just three more months of life. Today, Dr…

Agendia expands laboratory capacity

Agendia announced the official opening of its new headquarters at Amsterdam's Science Park at Watergraafsmeer, Kruislaan 406. The Grand Opening ceremony was officiated by Dr. Rene Bernards, Chief Scientific Officer at Agendia and the Honourable Director General Mrs. R.M. Bergkamp, on behalf of the Honourable Mrs. Maria van der Hoeven, Minster of Economic Affairs for The Netherlands.

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Speeding up vaccine production

During the race to produce vaccines against evolving influenza viruses the slowness of their manufacture has turned producers more sharply towards cell culture technology. Using the traditional process, fertilised chicken eggs must first be inoculated with live flu virus, then the resulting egg-adapted virus must be purified and inactivated to produce trivalent inactivated virus (TIV), during…

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Innovative technology for automated lymph node analysis

Lymph nodes play a critical role in the assessment of the spread of cancer, but identifying lymph nodes in surrounding tissue is a difficult task for most image analysis technology. German medical imaging company Definiens now introduced at RSNA 2008 its first computer-aided detection (CAD) application, Lymph Expert, that allows radiologists to identify and analyse lymph nodes volumetrically and…

Celiac test kits match multi-centre study demands

The results of the recent Multi-Centre Celiac Serology Study undertaken to define the optimal serological screening approach to Celiac Disease clearly showed that dual or combined isotype (IgA+IgG) transglutaminase screening can be advocated as a sensitive and specific alternative to endomysial antibody testing in the assessment of Celiac Disease.

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ProVision 80

ProVision 80, a shared-service colour Doppler all-digital system, provides an all-in-one solution for abdominal, obstetrics/gynaecology, cardiovascular, small parts, paediatric, and musculoskeletal applications, the manufacturer Chison Medical Imaging Co. reports.

WHO's FRAX incorporated into Hologic's bone densitometers

Led by Professor John Kanis, the World Health Organisation Collaborating Centre for Metabolic Bone Diseases, at Sheffield University Medical School, UK, developed FRAX. This algorithm is based on individual patient models that integrate the risks associated with clinical risk factors as well as bone mineral density (BMD) at the femoral neck to calculate a patient's 10-year fracture risk.

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Hopes for new treatment

Researchers have discovered a potential new treatment for diabetes by isolating and killing defective cells which prevent the natural production of insulin. The investigation opens the door to a potential therapy for patients with type 1 diabetes.

How save are antiangiogenic and anti-inflammatory drugs really?

Since Rofecoxib (Vioxx) was withdrawn from the worldwide market based on the safety findings of the Adenomatous Polyp Prevention on Vioxx (APPROVe) study, the uncertainty around the cardiovascular safety of NSAIDs and COX-2 inhibitors remains and leaves practitioners with difficult management decisions for the hundreds of millions of patients worldwide who continue to require pain-relieving…

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Agendia: New labs in Amsterdam

Last month Agendia announced the official opening of the company's new headquarters at Amsterdam's Science Park. The new facilities offer 13,000 square feet of laboratory and office space to support the company's molecular diagnostic cancer testing services and research activities.

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RFID technology may mess up medical equipment

Considered optimal transportation and identification tools, they have become a symbol for modern hospitals: RFID tags. But according to a new study radio frequency identification devices (RFID) may disrupt medical devices. Moreover, the FDA is concerned that the increase in digital technology might be dangerous for patients.

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Image processing

dicomPACS, developed by the German manufacturer OR Technology in partnership with medical specialists, is now installed in 5,000 workstations globally, because, `It is set apart by a very clear and user friendly structure,´ OR points out.

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OSIRIX

Designed by a team of radiologists, the latest release of OsiriX 3.0.1 on the Mac Pro 8-core was demonstrated for the first time at the recent European Congress of Radiology (ECR). OsiriX - a powerful image processing software dedicated to DICOM images (.dcm / DCM extension) produced by imaging equipment (MRI, CT, PET, PET-CT etc.) and confocal microscopy (LSM and BioRAD-PIC format) - a…

On the near horizon

The first FDA-approved prescription medication that reduces blood phenylalanine (Phe) levels in patients with Phenylketonuria (PKU) — a genetic disorder that prevents the normal use of protein foods and can lead to impaired brain development if untreated — could result in more regular screening of blood phenylalanine (Phe) levels in PKU patients.

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Type 2 diabetes driving epidemic

Type 2 diabetes poses one of the greatest public health threats of the 21st century. The majority of the western world is in the grips of a diabetes epidemic driven by type 2 diabetes that goes hand in hand with the escalating incidence of obesity. Alarmingly, in some working class and poor communities, the disease is so prevalent that its victims almost take it as a matter of course.

FDA works with outdated IT Systems

USA - Outdated and broken IT systems are blamed for slowness of the Federal Drugs Administration (FDA) reviews of foreign drugs, said former FDA officials and the Government Accountability Office (GAO) during a House Energy and Commerce Oversight Investigations Subcommittee hearing.

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The SMARTube

SMARTube technology enables super-stimulation of lymphocytes, which leads to enhanced production of antibodies in vitro. This enables better and earlier detection of infections.

Device helps heal the meniscus

Faced with meniscus injuries surgeons usually decide to remove the torn meniscal cartilage, which typically leaves the deficient knee vulnerable to future arthritis, because the padding that provides shock absorption and joint stability has been removed, causing bone to rub on bone.

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Article • Neuropelveology

Forging links between neurology and surgery

Surgery in the lower pelvic region often involves injury to or severing of nerve tissue. As in chronic diseases of the nervous system, the result can be pain, sensory disturbances or loss of function. Up to now the poor view of the nerves, partially formed of fine interwoven networks, has been one of the major problems – exacerbated by the strict division of skills between neurologists and…

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Molecular imaging

In recent years molecular imaging has developed into a hot topic field in medical research, which raised high expectations.

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AACC emphasises preventive diagnostics

San Diego, California - 20,000 international physicians, scientists and other visitors travelled to the Annual Meeting & Clinical Lab Expo of the American Association for Clinical Chemistry (AACC) in July, and 750 exhibitors emphasised the increasing importance of this gathering

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Novartis launched once-a-year osteoporosis treatment

The Swiss company Novartis recently received the FDA approval for the U.S. market for their new osteoporosis drug “Reclast”, a therapy that is only given once a year via a 15-minute infusion. The new treatment option is especially designed for women who suffer from post-menopausal osteoporosis.

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Treating Alzheimer with a skin patch

“Exelon Patch”, developed by Novartis is the first skin patch to treat patients with mild to moderate Alzheimer disease. The new therapy that has already been approved by the FDA, is said to be more compliant for it causes less incidents of nausea and vomiting.

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What's your prediction for MR? 'Expect the unexpected'

Since April, there's been a new man at GE Healthcare´s global MRI division; its new Vice President and General Manager is James E Davis. Meike Lerner caught up with him during the International Society for Magnetic Resonance in Medicine Congress, held recently in Berlin

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Exclusive dry long film for digital CR/DR

XL, an exclusive, dry, long film for use in the Horizon XL printer - currently the only digital long film imager on the market - promises to not only to reduce costs, save space, and completely eliminate wet film processing needs, but also to enhance orthopaedic studies of paediatric and adult spines, scoliosis and long bone hip-to-ankle.

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Agfa HealthCare launches new digital mammography functionality within IMPAX™

At RSNA, Agfa HealthCare introduced a range of functional extensions for digital mammography reading and reporting applications on its industry leading IMPAX™ PACS platform. The company launched IMPAX 6.2 integrated with CAD and MRS® Reporting as well as showing a work-in-progress of a new software application that addresses the growing need for digital mammography screening.

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Test identifies patients who benefit from targeted cancer drugs

USA - A new laboratory test - EGFRx, developed by the Weisenthal Cancer Group* - has accurately identified patients who would benefit from treatment with the molecularly-targeted anti-cancer therapies gefitinib (Iressa, AstraZeneca) and erlotinib (Tarceva, Genentech), according to clinical data published at the annual meeting of the American Society of Clinical Oncology (ASCO).

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Into the breast's depths

USA - Radiologists at Newton-Wellesley Hospital in Newton, Massachusetts have released findings from a breast cancer research study designed to evaluate the use of software from Advanced Image Enhancement, Inc (AIE) for examining regions of interest (ROI) with Hologic's Lorad Selenia digital mammography system.

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DMIST demystified

Cynthia E Keen discusses the controversy evoked by an ambitious 36-month digital mammography trial that has cost the US $26,000,000

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How to manage your radiologist

Radiology in public hospitals is under economic pressure due to limited public funding, partially decreasing radiology fees, capitation payment systems, central planning of capital investment, as well as the increasing complexity and cost of equipment.

Breast cancer

Five years of therapy with the drug tamoxifen has become the norm for postmenopausal women with hormone-sensitive breast cancer. However, this has several adverse side effects, and studies have continued to compare the effects of other drug therapies with tamoxifen.

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