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 Martin A. Makary said the agency is taking aggressive steps to modernize outdated regulations, expand ...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

A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its ...

A new Food and Drug Administration AI tool that could speed up reviews and approvals of medical devices such as pacemakers ...

Alex Ratner, CEO of Snorkel AI, remembers a time when data labeling —the grueling task of adding context to swathes of raw ...

There is a nearly five-year gap between when a new medical device receives FDA approval and is subsequently covered by ...

The U.S. Food and Drug Administration said on Monday that it had launched a generative AI tool, Elsa, aimed at improving ...

The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen ...