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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
The FDA has given Class I designation, the highest level of risk, to Avanos Medical’s March 21 recall of its Cortrak*2 enteral access system because of the potential for serious patient injury or death if the device is misused. Read More
In a new guidance on ethical issues, the Advanced Medical Technology Association (AdvaMed) advises against letting a device company’s sales department select as trainers if the company aims to implement bona fide training and education programs for healthcare professionals (HCPs). Read More
Manufacturers of legacy devices that were not designed with cybersecurity in mind must tell customers during the procurement process when they will stop providing cybersecurity support, the International Medical Device Regulators Forum (IMDRF) advises in a just-published draft document. Read More
The FDA was slow to begin phasing out its policy that allowed the emergency authorization of hundreds of COVID-19 tests before their efficacy was proven. Read More
Under FDA medical device regulations, all products must be fully verified, generally by postproduction test or inspection, to ensure that they meet each of their design specifications. The agency defines a product as anything created by a process, including individual components of a device, materials involved in manufacturing the device — whether or not those materials are a part of the finished device — and even the in-process device itself. Read More