STAT

Beyond detection: In the age of clinical AI, what counts as an FDA ‘breakthrough’ medical device?

An analysis of AI-powered devices that received FDA's "breakthrough" label shows a preference for big-picture, multi-problem ...
Medical Design & Outsourcing

FDA removes pediatric VADs from device shortage list, adds others

The FDA has removed pediatric ventricular assist bypass devices (VADs) from its device shortage list in an update this month.
Regulatory Affairs Professionals Society

FDA warns device maker, contract testing lab for GMP violations

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...
Yahoo

FDA announces regulatory exemptions for ‘non-medical grade’ devices

Add Yahoo as a preferred source to see more of our stories on Google. FDA commissioner Marty Makary made the announcement during the 2026 CES trade show The US Food and Drug Administration (FDA) is ...
Regulatory Affairs Professionals Society

FDA finalizes guidance on patient preference information for devices

The US Food and Drug Administration (FDA) has finalized guidance on incorporating patient preference information (PPI) for assessing the benefit-risk profile of certain medical devices throughout the ...
NBC DFW

FDA moves to rehire medical device staffers fired only days earlier

Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning Friday night, FDA ...
MD&M East

FDA's Deregulation of Wellness Devices Is a Slippery Slope

Like many in the medtech industry, I was initially optimistic when FDA announced its revised guidance on wearable wellness devices. For years, the industry has called for clearer, more predictable ...