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Members of Congress from both parties have asked the Centers for Medicare and Medicaid Services (CMS) to take action to deal with “preventable error” leading to false-positive results from blood tests used in the diagnosis of sepsis. Read More
The FDA’s proposed rule on over-the-counter (OTC) hearing aids does not introduce a new device classification, but is more “like a rule of the road,” explained Ian Ostermiller, policy adviser in the FDA’s Office of Policy, during a Tuesday webinar hosted by the agency. Read More
Louisville, Ky.-based devicemaker Induction Therapies has been marketing a microneedling product without FDA approval, the agency said in a warning letter to the company. Read More
Device manufacturing facility workers are routinely exposed to biohazards when they reprocess devices for reuse, even when they are wearing personal protective equipment, researchers have found. Read More
Device industry groups are hesitant to fully endorse the FDA’s push for greater transparency by manufacturers in the labeling information they provide to users of their artificial intelligence- or machine learning-enabled devices. Read More
Roche has acquired Germany-based TIB Molbiol, a long-time partner on diagnostic products, and the company has just released three new tests that can differentiate mutations in the Omicron variant of the SARS-CoV-2 virus. Read More
The FDA is expanding the applications that can be made using its electronic Submission Template and Resource (eSTAR) filing system from 510(k) clearance requests to include de novo device applications. Read More
There are no one-size-fits-all methods for modeling cybersecurity threats facing medical devices, but developers and manufacturers of medical devices can help mitigate the threats by considering four simple questions suggests a new “playbook” endorsed by the FDA. Read More
Medical device recalls increased by more than 35 percent to 235 incidents in the third quarter of 2021, up from just 173 in the second quarter, reversing a year-long trend of declining numbers, a new analysis suggests. Read More
The European Commission has released the first opinion by an expert panel assessing a product for compliance with the EU’s In Vitro Diagnostics Regulation (IVDR), which will go into effect on May 26, 2022. Read More
Invacare has received a warning letter from the FDA for — among other failures — not fully investigating an incident in which a patient who was using one of its oxygen concentrators had to be taken to the hospital in an ambulance because the device wasn’t producing enough oxygen. Read More
Sixty-one senators of both parties have sent a letter urging the Centers for Medicare & Medicaid Services (CMS) to find a way for Medicare to pay for breakthrough medical devices, after the agency withdrew a previous proposal to do so. Read More