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Medtronic has filed a patent infringement lawsuit against Axonics in two venues and also faces a Class I recall of its Duet system used to drain cerebrospinal fluid. Read More
The FDA’s draft guidance describing how device manufacturers can use real-world evidence (RWE) to support regulatory applications is a good start, but needs some refinement to avoid becoming a burden on manufacturers, according to many of the 28 comments posted. Read More
Soft tissue markers BioZorb and BioZorb LP pose a potential risk of serious complications said the FDA in a safety communication released Tuesday. Read More
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
A student group that filed a citizen petition aimed at improving what it alleges are “hugely deficient” trial reporting enforcement efforts by the FDA has gained some ground in the ongoing effort to increase trial transparency, with the agency granting one of its requests and pledging to consider another. Read More
Companies seeking approval for medical devices that contain AI are still asked to jump through the basic regulatory hoops inherent in trying to bring any new device to market — but now the FDA is increasing its expertise in AI and asking for more data. Read More