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The U.S. Patent Trial and Appeal Board (PTAB) stood with Apple in its complaint that former partner AliveCor’s claims on the technology behind wearable Afib detection were unpatentable.
The EU Medical Device Coordination Group (MDCG) has proposed a new definition of hybrid audits, suggesting that there should be at least one auditor in a facility premises — at some point — during an audit by a notified body, with off-site team members participating using information and communication technologies.
The FDA has approved new safety labeling for Endologix’s AFX2 endovascular graft systems, which is used to treat patients with abdominal aortic aneurysm (AAA).
The FDA should take a page out of one online retail giant’s book, says Commissioner Robert Califf, as it works to update its technology infrastructure and make its processes and interactions with industry as efficient as possible. Read More
Brisbane, Calif.-based Cutera, a manufacturer of medical aesthetic and dermatology devices, was hit with an FDA warning letter for a still-functioning website for a vaginal rejuvenation product the company removed from the market in 2019. Read More
How to tell whether clinical decision support (CDS) software is exempt from classification as a medical device was the focus of a webinar last week sponsored by the Food and Drug Law Institute. Read More
The Swiss Parliament has cleared the way for legislation to allow non-CE-marked medical devices — including those approved or cleared by the FDA — to be marketed in Switzerland, where only CE-marked medical devices are currently available. Read More
Speakers at a Food and Drug Law Institute virtual meeting on digital health technology last week agreed that a coordinated vulnerability disclosure (CVD) process is needed to address cybersecurity threats to medical devices. Read More
“Individuals need to understand how their data is being collected … and managed and how they can delete their data,” said Jonelle Sauders, associate product counsel for Google Health. Read More
Devicemakers are having difficulty making sense of a recent FDA final guidance targeting clinical decision support software (CDS) for machine learning (ML) products, according to remarks made during a virtual panel held Thursday by the Food and Drug Law Institute (FDLI). Read More