FDA Cleared 1,357 AI Devices. Three Were Tested on Patients.
A PLOS Digital Health analysis found that only 3 of 1,357 FDA-cleared AI/ML medical devices were ever evaluated on patient outcomes. Clearance certifies substantial equivalence to a predicate, not benefit — so health systems have to write the evidence, subgroup coverage and drift monitoring into procurement themselves.
August 19, 2026 · 11 min read