Perfectly viable medical devices disappearing from the European market, manufacturers walking away from the EU rather than navigating regulatory demands, patients losing access to products with long, well-documented safety records. The implementation process for the MDR and IVDR has been challenging, to put it mildly – and the journey is far from over. Ahead of the EAAR’s MDR/IVDR Summit…
Affordable all-in-one mobile digital radiography solution Compact design with fully collapsible column that provides effortless maneuverability and navigation through tight spaces with motor-assisted inching from the tube headOn-board detector charging Convenient storage for wireless detectors, grids, batteries, wipes, and lead apron Fully integrated DELWORKS DR workstation with…
Europe’s healthcare systems face growing pressure: fewer staff, higher infection-control demands, and increased documentation. Estonia is already built for this. With 99% of health data digital, digital trust is built into everyday healthcare – giving Estonian companies a strong foundation for efficient collaboration, fast traceability, and AI-supported operations.
The use of surgical robots offers a wide range of possibilities, but in Europe the technology is often unable to reach its full potential. Dr. med. Christoph Wandhöfer explains why.
With the Eluxeo® 8000 system, Fujifilm Healthcare Europe is bringing their latest in endoscopy to European markets. The system – the first in an all-new series – features new therapeutic capabilities, workflow management and improved image quality.
While the Medical Device Regulation was designed to enhance safety and quality, its complexity and certification costs threaten the availability of vital devices. Cardiologists urge for revision.
Transmission of tuberculosis (TB) in the European Region is still ongoing, and immediate public health measures are needed to control and reduce the growing burden of the disease, experts urge.
A newly-developed robot can detect medication side-effects in patients after heart arrhythmia treatment faster than a human doctor, while reducing the number of follow-up tests.
Klebsiella is among the top three pathogens responsible for hospital-acquired infections (HAIs). Now, researchers discovered why the bacteria thrive in clinical environments.
Could the 'gene scissors' CRISPR be used to make resistant bacteria susceptible to first-line antibiotics again? According to new reseach, yes – but the experts also point out serious caveats.
Researchers have analysed the rise of antibiotic resistance over the last 20 years in the UK and Norway, highlighting that antibiotic use is not the only factor in the increase.
The Medica in Düsseldorf once again solidified its status as one of the largest medical trade fairs worldwide this year - and Rein Medical seized the opportunity to present a selection of its product portfolio.
Philips and Quibim have signed a multi-year agreement to work on an integrated solution including an AI-based software to automate real-time prostate gland segmentation in MR images.
Medical imaging and healthcare IT company Esaote reports that it has completed the transition of its medical devices to comply with the new Medical Device Regulation (MDR).
A custom-made new hip, a knee or maybe a piece of bone? The technology and possibilities for 3D printing are (almost) there. And such an implant from a 3D printer has many advantages, not only for the patient, but also for the surgeon who has to perform the operation. Koen Willemsen, physician, and medical engineer at the University Medical Center Utrecht (UMCU), was at the cradle of the 3D lab…
Nowadays, the operating theatre is networked and staff have access to a wide range of information and image data. With the Clinio, Rein Medical offers a medical all-in-one (AIO) computer that has been designed for use in hygienically sensitive areas.
At the European Congress of Radiology (ECR) in Vienna, Fujifilm Europe showcased a new flexible, hybrid C-arm and portable x-ray machine, called FDR Cross.
The pandemic has put a spotlight on the increasing role of cyberattacks and weaknesses in healthcare. In healthcare as in other industries, cybercrime does not stop at national borders. With this idea in mind, the US consulate general in Düsseldorf and the US embassy in Vienna recently invited interested parties to their Cybersecurity in Healthcare Briefing.
Using cutting-edge genomic sequencing techniques, researchers at the University of Oxford have identified almost all the genomic variation that gives people resistance to 13 of the most common tuberculosis (TB) drug treatments. The Comprehensive Resistance Prediction for Tuberculosis International Consortium (CRyPTIC) research project has collected the largest ever global dataset of clinical M.…
Agfa HealthCare is proud to be one of the first companies to receive the new European Medical Device Regulation (MDR) certification, which was issued by Intertek on 25 August 2021. This certification, which covers Agfa HealthCare’s Class IIa Enterprise Imaging and Xero Viewer solutions, ensures that Agfa HealthCare can continue to deliver to customers innovative solutions that meet their real…
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.
OPERION from Rein Medical has been an established byword for wall-integrated monitors and workstations for the operating theatre for ten years. Now in their 3rd generation, they stand for hygienic, highly compatible, reliable and intuitive monitor and workstation systems. The extensive product range in sizes from 21.5" to 75" means that perfect hardware packages covering any requirement…
With new Medical Device Regulations (MDR) now in force across Europe, the UK has chosen to retain pre-existing rules while also introducing mechanisms to allow it to draw up separate rulings for the sector in the future. The MDR took effect on May 26, aiming to harmonise and strengthen the pre-existing regulatory regime for medical devices, and enhance protection for consumers.
26 May 2021 marks the Date of Application of the European Medical Device Regulation (MDR). Replacing the Medical Devices and Active Implantable Medical Devices Directives, the Regulation is a welcome update for patient safety, transparency, and access to medical devices for Europeans. COCIR has been contributing to the development and implementation of the MDR since the very first discussions in…
New regulations covering medical devices are set to come into effect across Europe. Originally intended to be implemented in May 2020, the introduction of the updated Medical Device Regulation (MDR) was delayed because of the coronavirus pandemic. The new regulations – the first major update in three decades – now come into force on May 26, and to mark the date a special conference discussed…
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…
Scientists at Nanyang Technological University, Singapore (NTU Singapore) have developed a synthetic peptide that can make multidrug-resistant bacteria sensitive to antibiotics again when used together with traditional antibiotics, offering hope for the prospect of a combination treatment strategy to tackle certain antibiotic-tolerant infections.
Austria-based cochlear and hearing implants technology company Med-El has become one of the first manufacturers worldwide, and the first and only hearing implant manufacturer in the world, to be granted European Medical Device Regulation (MDR) certification. The company made an initial announcement on the newly earned certification after making an early commitment to adopt the MDR in 2016. For…
The intentions behind the Medical Device Regulation (MDR) are good. Ultimately, the regulations should prevent inferior medical devices, technologies and pharmaceuticals from endangering peoples’ lives while increasing the quality of drugs and devices entering the market. At the same time, MDR could present several serious immediate challenges to European healthcare systems.
The MKC-X800 ultra-compact camera is a new addition to Ikegami’s range of medical imaging equipment, which, the firm reports, sets higher than ever standards of imaging quality to capture the precise colour and image detail of surgical operations. Measuring just 28x28x52mm WHD and weighing 100g, it can be mounted on a surgical microscope, lightweight support stand or boom. With its 4K-native…
In practice, the drying of the endoscope is often underestimated and therefore a possible pitfall for hygiene and reprocessing steps. As the importance of endoscopic retrograde cholangio-pancreatography (ERCP) procedures and their impact on patients’ lives remains unwavering, the medical community is continuously looking for ways to improve this field of expertise. What better way to learn more…
Many countries across the world are challenged with a rising number of incidences of multi-drug resistant (MDR) organisms infecting the population, and for several years, a clear pattern of increased resistance has emerged in southern and eastern European countries. For example, in countries such as Italy, a reduced number of therapeutic options remain available for highly pathogenic infections,…
Sixty-two percent of Germans fear antibiotic resistance, according to a survey recently conducted by the German Federal Institute for Risk Assessment. ‘Patients colonised by multi-resistant pathogens are particularly scared. But many of these fears are rooted in misunderstandings,’ explained Professor Mathias Pletz at the Congress for Infectious Diseases and Tropical Medicine (KIT).
Designing medical imaging systems for surgical, ophthalmology and microscope-mounting applications, Ikegami Tsushinki Co. Ltd, from Tokyo, Japan, is showing the latest additions to its range of medical cameras and medical-grade displays. ‘The new MKC-X800 is a progressive-scan camera with an ultra-high-sensitivity 4K-native CMOS imager,’ Ikegami reports. ‘Measuring just 34 x 40 x 40 mm, the…
By 2020 medical devices manufacturers must document the clinical effectiveness of their devices more extensively. The Medical Device Regulation (MDR) presents a fundamental impact on innovation and price calculation for medical devices. Since the faulty PIP breast implants scandal in France (March 2010), there have been frequent calls for tighter licensing regulations for medical devices within…
Scientists in the UK have developed a new model that will help to advance the study of resistance to antibiotics.
COCIR welcomes the adoption of the Medical Device Regulation (MDR) after successful vote during the European Parliament Plenary Session today. These new rules should allow for continuing improvement to the safety of medical devices, benefitting patients and ensure timely access to innovative healthcare technology.
Multidrug-resistant tuberculosis (MDR-TB) is widespread globally, with an estimated 480,000 cases in 2014.Although rare in European countries, the risks posed by the current migrant crisis makes MDR-TB an important and urgent public health priority.
European regulators have turned the world of in vitro diagnostics (IVDs) upside down with new legislation that will come into effect at the end of this year. The new EU legislation gives manufacturers five years to meet strict standards. That may not be enough time.
Multidrug resistance (MDR) is the mechanism by which many cancers develop resistance to chemotherapy drugs, resulting in minimal cell death and the expansion of drug-resistant tumors. To address the problem of resistance, researchers at the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health (NIH) have developed nanoparticles that…
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.
Virtual observation of patients taking prescribed TB medication could prove an effective technique to ensure they effectively complete their treatment course, according to research presented at the European Respiratory Society (ERS) Annual Congress held in Barcelona.
The German Medical Technology Association BVMed is asking the European Commission, the Council and the Parliament to take immediate action in bringing forward appropriate measures to improve the designation and surveillance of notified bodies and market surveillance of medical devices.
With few experts, we need to raise awareness among physicians and undertake research to upgrade our knowledge of this disease
The International Council of Nurses (ICN) has launched an exciting, informative and practical toolkit for everyone involved in TB care and control. Entitled “Risk Reduction and Inter-Professional Collaboration for TB Infection Control”, it comes at a time when increasing numbers of health care workers are falling victim to this preventable and curable disease.
Although powerful, new, targeted treatments are regularly introduced to cancer clinics, choices for the first-line treatment of invasive breast cancer normally lie between preventive surgery and chemotherapy. A recent American study used genomic prediction combining multiple signatures to determine outcomes to standard chemotherapy.
The threat of communicable diseases will become even worse in the near future. At the European Health Forum Gastein, the European Union's leading health policy congress for experts and decision-makers, experts stressed that there are a number of risk factors which contribute to a growing risk of the spread of communicable diseases into Europe, namely into the European Union.
GenoType® MTBDR plus, a new molecular test for multidrug-resistant tuberculosis has recently been approved in Europe. The test, developed by the Foundation for Innovative New Diagnostics (FIND) and Hain Lifescience, offers a fast solution to detect MDR-TB and XDR-TB at a reasonable price, a good condition for the application in poorer countries.
Pharma company Eli Lilly has increased an existing partnership with the World Medical Association (WMA) by granting c. 646,505 euros to expand online training courses for physicians on multi-drug resistant tuberculosis (MDR-TB), which they have been developed over the past year.
By putting the World TB Day slogan 'I am stopping TB' into action, 11 nurses have earned the 2008 ICN/Lilly Award, for their outstanding work in fighting tuberculosis (TB) and multi-drug resistant TB (MDR-TB)[1]. The award recipients come from six TB affected countries: from Kenya (Diana Jelegat Kipsoisoi), Lesotho (Likhapha Ntlamelle ), Malawi (Chrisie Bwazi, Rodwell Gundo and Shouts Simeza),…
The WHO-Euro region ranges from Portugal to the East Asian parts of Russia, including Central Asia and the Southern Caucasus. Because of the increasing numbers of tuberculosis and rates of multidrug resistance (MDR TB), tuberculosis was declared a regional emergency in 2004.
By Professor Giovanni Battista Migliori MD, Director of the WHO Collaborating Centre for Control of Tuberculosis and Lung Diseases.
TB causes three million deaths annually, ranking it higher than any other infectious disease. And TB has resurged in Europe. In August, the British Thoracic Society, British Lung Foundation and TB Alert highlighted its increase in over the last 15 years in the UK alone.
