The FDA has released a database of artificial intelligence-powered medical devices authorized for use. The database contains publicly available data on AI and machine learning-enabled devices. The FDA ...

On Wednesday, Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) sent a letter asking FDA to overhaul two databases that provide public information about medical device safety. The letter ...

The U.S. Food and Drug Administration and the National Library of Medicine have partnered to launch a portal making unique device identification information available to the public. In 2013, the FDA ...

Since launching in 2017, an ambitious and secretive Food and Drug Administration program to speed up medical device development has helped at least 44 authorized devices hit the market. There are now ...

The Food and Drug Administration has acknowledged that more than 56,000 never-before-disclosed surgical stapler malfunctions were quietly reported to the agency from 2011 through 2018. The newly ...

Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug ...