The agency's Digital Health Advisory Committee will meet on November 6 and focus on how these digital tools could help ...

Dr. Erik Langhoff, chief medical officer and consultant for the Bronx Regional Health Information Organization, discusses how ...

Commenters to the FDA also advocated for safety reforms and for industry funds to be used for post-market monitoring.

The number of medical devices with artificial intelligence technology has risen sharply in the past decade. The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices ...

The FDA will convene experts on Nov. 6 to discuss challenges around regulating mental health products that use artificial ...

Lisa E. Geary, left, and Cody J. Madison, right, of Eckert Seamans Cherin & Mellott. Courtesy photos Artificial intelligence (AI), particularly machine learning (ML), is revolutionizing health care ...

Oct. 16, 2024 — Before the FDA allows prescription medicines on the market, drugmakers must prove they’re safe and effective. What’s less widely known is that most medical devices — including those ...

ICUI faces an FDA recall of its Plum Duo Infusion System over software flaws, though devices remain in use, pending fixes.

The FDA will convene its Digital Health Advisory Committee Nov. 6 to discuss the use of generative artificial ...