In May 2022 a shortage of several lab tests may come as many manufacturers struggle to comply with EU regulation requirements covering in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746). Even modified tests and laboratory-developed tests will present a problem for hospitals and labs as explained by Dr Thomas Streichert.
Whole genome sequencing (WGS) from a single blood test picks up 31% more cases of rare genetic disorders than standard tests, shortening the ‘diagnostic odyssey’ that affected families experience, and providing huge opportunities for future research.
Researchers have leveraged the power of digital pathology and computational modeling to detect and quantify podocytes, a specialized type of cell in the kidney that undergoes damaging changes during early-stage kidney disease.
Researchers at the Catharina Heart and Vascular Center, together with Eindhoven University of Technology, have developed a new measurement method to analyze the smallest capillaries of the heart by measuring blood flow and resistance. The new method to assess coronary microcirculation allows cardiologists to make a clearer diagnosis. Until recently, the tests used for this purpose were not…
A new rapid molecular diagnostic test from Cepheid has received the CE mark for distribution in the European market. The test, called Xpert Xpress CoV-2/Flu/RSV plus, is designed for qualitative detection of the viruses causing Covid-19, Flu A, Flu B, and respiratory syncytial virus (RSV) infections from a single patient sample. The new plus version of the test provides a third gene target for…
Researchers at Karolinska Institutet have developed an AI-based tool that improves the diagnosis of breast cancer tumours and the ability to predict the risk of recurrence. The greater diagnostic precision can lead to more personalised treatment for the large group of breast cancer patients with intermediate risk tumours. The results are published in the scientific journal Annals of Oncology.
The FDA authorized marketing of software to assist medical professionals who examine body tissues in the detection of areas that are suspicious for cancer as an adjunct to the review of digitally-scanned slide images from prostate biopsies.
A two-minute passive-test that measures people’s brain waves in response to a series of images, 'Fastball EEG', could help expand early dementia diagnosis.
The role of Artificial Intelligence (AI) is one of the most divisive issues in cardiology. Two leading experts argue the pros and cons of its use, exploring its benefits and advantages to cardiac care, as well as highlighting the pitfalls and shortcomings of AI, while underlining the need for clear guidelines and regulations for its use going forward.
MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, ran an industry survey, which shows an urgent, high risk to the availability of IVD medical tests once the new IVD Regulation fully applies.
Markers in our blood – ‘fingerprints’ of infection – could help identify individuals who have been infected by SARS-CoV-2, the coronavirus that causes Covid-19, several months after infection even if the individual had only mild symptoms or showed no symptoms at all, say Cambridge researchers. The team has received funding from the National Institute for Health Research to develop a test…
Pancreatic cancer is one of the deadliest cancers in the world, and one of the most difficult to treat. In 2020, an estimated 495,000 individuals worldwide were diagnosed with pancreatic cancer and an estimated 466,000 died, according to statistics from the World Health Organization’s International Agency for Research on Cancer. Most patients with advanced disease die within a year of…
University of Washington researchers have discovered that AI models—like humans—have a tendency to look for shortcuts. In the case of AI-assisted disease detection, these shortcuts could lead to diagnostic errors if deployed in clinical settings.
The EU-funded consortium Laser and Ultrasound Co-analyzer for Thyroid Nodules (LUCA) has developed a non-invasive, low-cost device that brings a new solution for thyroid cancer screening.
Handheld laser devices that help surgeons quickly spot liver damage could transform transplant procedures, research suggests. The non-invasive technique could provide medical staff with instant data on the health of donor livers and help them to identify which organs are suitable for transplant. If widely adopted, the light-based tool could allow more livers to be transplanted safely and…
CliniSys Group aims to help healthcare professionals test, diagnose and treat millions of patients every day, saving or improving quality of life, the company reports. "CliniSys is a trusted partner to hospitals and private healthcare organisations across Europe. We routinely provide reliable, intuitive diagnostics solutions that help healthcare professionals spend more time focusing on…
Fujifilm Europe GmbH is launching the new “Harmony” version of its Amulet Innovality mammography system. The “Harmony” version brings together improved diagnostic performance with new design themes to embellish and illuminate your mammography suite, creating an environment to put your patients at ease.
A major study from the Washington University School of Medicine details numerous long-term effects of COVID-19, pointing to massive health burden.
Fluxergy envisions that a fully articulated democratized testing health system has the potential to reduce the likelihood and the ultimate severity of pandemics like Covid-19. Our mission is to unlock the true potential of diagnostics to play a far greater and more important role in the early detection of diseases and ongoing monitoring of health status, where and when it matters most: at the…
Kobe University Hospital’s Dr. Makoto Nishimori and Project Assistant Professor Kunihiko Kiuchi et al. (of the Division of Cardiovascular Medicine, Department of Internal Medicine) have developed an AI that uses multiple kinds of test data to predict the location of surplus pathways in the heart called ‘accessory pathways’, which cause the heart to beat irregularly. In this study, the…
Now Available: The Fluxergy Analyzer System is a testing platform designed for sample-to-answer point-of-care testing, enabling clinicians to cost-effectively conduct molecular in vitro diagnostic tests. The analyzer system is designed to deliver test results within one hour. This device is solely intended to be used by healthcare professionals.
Thermo Fisher Scientific and Artificial have announced a strategic technology collaboration to develop an integrated and comprehensive software automation platform for Thermo Fisher’s standardized COVID-19 Testing Platform. The integration will result in increased testing throughput and support global healthcare initiatives.
Rapid tests, PCR tests, self-tests… there are many test options to determine contamination with Covid-19. In most this is done by inserting a cotton swab deep into the nose and/or throat to extract some mucus – unpleasant for adults and often a drama for children. Towards the end of 2020, a new system emerged to rule out a Covid-19 contamination. The electronic SpiroNose performs a…
Systematic review finds that machine learning models for detecting and diagnosing Covid-19 from medical images have major flaws and biases, making them unsuitable for use in patients. However, researchers have suggested ways to remedy the problem. Researchers have found that out of the more than 300 Covid-19 machine learning models described in scientific papers in 2020, none of them is suitable…
It is possible to identify Parkinson’s Disease based on compounds found on the surface of skin, according to new research. The findings offer hope that a pioneering new test could be developed to diagnose the degenerative condition through a simple and painless skin swab. Scientists at The University of Manchester have developed a technique which works by analysing compounds found in sebum -…