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The EU’s Medical Device Coordination Group (MDCG) clarifies in a new guidance that seemingly minor changes can make it necessary for a device manufacturer to assign a new UDI-DI to a product. Read More
Devicemakers are asking for more time to implement the FDA proposed rule that aims to harmonize the agency’s Quality System Regulation (QSR) with the International Organization for Standardization (ISO) 13485 standard. Read More
San Diego, Calif.-based Illumina has secured a CE mark in Europe for its TruSight Oncology (TSO) comprehensive assay that can now be used as a companion diagnostic to identify cancer patients with a rare gene mutation for treatment with Bayer’s Vitrakvi (larotrectinib). Read More
Boston Scientific’s Acurate neo2 transcatheter heart valve showed a “significantly lower” frequency of cardiac complications than earlier versions of the device, Italian researchers reported in the journal of the American College of Cardiology. Read More
A proposed regulation issued by the FDA today would amend current Good Manufacturing Practice (cGMP) rules for combination products containing medical gases, focusing on requirements for standardized labeling and manufacturing procedures specifically for drug-device combinations. Read More
In a recently promised update on medical device reports (MDR) associated with suspected foam breakdown in certain Philips Respironics devices, the FDA reports it received more than 21,000 MDRs, including 124 reports of deaths, from April 2021 through April 2022. Some of the injuries noted by the FDA include cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, difficulty breathing, dizziness, nodules and chest pain. Read More
Medtronic released interim results showing that its Evolut transcatheter aortic valve replacement (TAVR) system resulted in a low level of complications and death when implanted using a specific technique. Read More
Pharmaceutical manufacturers are playing something of a shell game with inhalers, maintaining their patents and market exclusivity with new products that aren’t really new, according to research reported in the journal Health Affairs. Read More
Early results from a clinical study showed a significant improvement in patients’ quality of life and an improvement in their sleep quality, the company said. Read More
A proposed in vitro diagnostics reform bill that may end up in legislation reauthorizing device user fees could have a chilling effect on the development of infectious disease-specific tests, warns the American Society for Microbiology (ASM). Read More
Parsippany, N.J.-based Extremity Medical has filed a federal patent lawsuit against competitor Fusion Orthopedics, claiming that the company, which was cofounded by a former Extremity sales representative, is infringing on two of its patents. Read More