The U.S. FDA’s device center is working to refine its regulation of artificial intelligence algorithms, but the agency is recommending that industry be more forward-thinking in a blog that urges device makers to fully adopt a life cycle management mindset for these systems.
The U.K. National Institute for Health and Care Excellence endorsed the use of testing for the CYP2C19 genotype for management of clopidogrel usage after ischemic stroke and heart attack, but the agency is specific about the use of tests by Genedrive plc and Genomadix Inc. in point-of-care settings as alternatives to lab testing.
The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.
U.S. federal preemption of state law for devices approved by the FDA is a matter of record, but a recent case affirms the staying power of Supreme Court jurisprudence on that point.
The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.
The U.S. Agency for Healthcare Research and Quality posted a request for information on the current state of multi-cancer screening tests for a review that poses several questions.
The U.S. CMS proposed a series of changes to the Medicare series of codes for diagnostic-related groups, and device makers had pointed remarks about some of those proposals.
The U.S. FDA proposed to overhaul guidances for maxillofacial systems that accumulated at least 18 years' of dust, in an effort to keep up to date with modern medical technology.
The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a year or two to emerge.
The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.
