In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s ...

Dr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a ...

Zeta Surgical announced that the FDA granted 510(k) clearance for its Zeta Navigation System for expanded capabilities.

FDA Commissioner Robert Califf calls it the “first intergovernmental health AI laboratory” that will test AI. The FDA ...

As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...

Since 2016, the Food and Drug Administration has received about 300 drug submissions that reference artificial intelligence, ...

It is commendable that CureMetrix is the first company to propel women’s healthcare to the heights of artificial intelligence ...

A brain-computer implant device by Blackrock Neurotech helps a man with ALS speak with an AI-powered voice Christina Jewett ...

SimBioSys announced that it received its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons ...

At the Coalition for Health AI’s Global Summit in Las Vegas, CHAI members gathered to tease out some of the most basic ...

“It’s essentially a place where you get rapid but effective evaluation — from FDA’s standpoint and from VA’s standpoint — on a potential new application of generative AI to, number one, make sure it ...

The FDA faces policy challenges as technological advances roil health care and the agency fights for resources from Congress — no matter who wins the election.