Skip to main content

For AI-based 'breakthrough' medical devices, Medicare coverage may become easier

By STAT News  
   July 31, 2025

Of the nearly 700 such devices captured in STAT’s Breakthrough Device Tracker, at least 10% use artificial intelligence. At least 16 have already been authorized by the FDA, and the unofficial count is still higher: STAT found examples of AI-based breakthrough devices that have been cleared by the FDA but have yet to be reported on the agency's public list of authorized breakthroughs, which was last updated in November. 

Full story


Get the latest on healthcare leadership in your inbox.