The FDA has expanded its Early Alert program to give the healthcare industry earlier visibility into potential high-risk medical device issues. The agency’s Center for Devices and Radiological Health ...

After a successful pilot, the agency has lifted the limitations on when it will provide early information about potentially ...

A new artificial intelligence tool can scan social media data to discover adverse events associated with consumer health ...

Instead of bright lights and an alarm, Blue Springs firefighters are wearing a new technology to wake them up more calmly.

The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial intelligence-enabled medical device ...