Most AI medical devices cleared for use were not tested on patient outcomes (IMAGE)

PLOS

Most AI medical devices cleared for use were not tested on patient outcomes

Caption

Growth of FDA-cleared AI/ML-enabled medical devices from 1995 to December 2025. Of 1,357 cleared devices, only 34 were linked to registered clinical trials and only 3 were evaluated for patient-centered outcomes. (Fig 1 of the article.)

 

Credit

Abulibdeh R, Cajas Ordóñez SA, Celi LA, Gorijavolu R, Izath N, Markussen Lunde T, 2026, PLOS Digital Health, CC-BY 4.0 (https://creativecommons.org/licenses/by/4.0/)

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