FDA cleared 1,357 medical AI devices, only 3 tested on patient outcomes
EricTopol · x · 2026-08-20
A study published in PLOS Digital Health reveals a significant gap in clinical trial evidence for FDA-cleared medical AI devices.
- Overview: Out of over 1,357 AI medical devices cleared or approved by the FDA, only 3 (0.2%) were tested for patient outcomes.
- Clinical Trials: Only 34 (2.5%) were linked to prospective, registered clinical trials.
The study highlights the disconnect between current regulatory approvals and actual verification of clinical benefits.
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