Nearly half of FDA-authorized AI tools may provide little benefit

Medical Economics October 1, 2024
Todd Shryock

Study shows that some AI tools aren’t worth much

A study led by a multi-institutional team of researchers from the University of North Carolina (UNC) School of Medicine, Duke University, Ally Bank, the University of Oxford, Columbia University and the University of Miami illustrates the need for rigorous clinical validation of artificial intelligence (AI) medical devices. Published in Nature Medicine, their research reveals that nearly half of the AI tools authorized by the U.S. FDA lack reported clinical validation data, raising concerns about their effectiveness and safety.

Sammy Chouffani El Fassi, an M.D. candidate at the UNC School of Medicine and research scholar at Duke Heart Center, along with Gail E. Henderson, Ph.D., a professor in the UNC Department of...

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