A new FDA artificial intelligence tool designed to streamline medical device reviews is faltering in its early rollout stages, raising concerns for agency staff and ethics experts about its ...

FDA Commissioner Dr. Martin A. Makary said the agency is taking aggressive steps to modernize outdated regulations, expand ...

Musk has previously stated that humans may be able to surf the web with their thoughts by the end of 2030, Reuters reported. The claim has drawn renewed attention amid the funding news. In January, ...

The FDA has opted to not appeal a federal court decision that struck down the agency’s rule to regulate laboratory-developed tests as medical devices. The 60-day window for appeal has passed, ...

HeartSciences (HSCS) announced that the U.S. Food and Drug Administration has granted Breakthrough Device designationless than BDD, for its Aortic ...