1,357 FDA-cleared AI medical devices, only 3 tested on patient outcomes: PLOS review
HealthcareLdr · x · 2026-09-07
A PLOS Digital Health review finds that 1,357 AI medical devices have received U.S. FDA clearance, but only 3 were actually tested on patient outcomes. Authors from the University of Toronto, MIT Critical Data, and Harvard highlight a regulatory gap: most clearances rely on technical metrics rather than clinical outcome evidence.
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