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Author

Nura Izath

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Review Open access Aug 2026

1,357 AI medical devices cleared, 3 actually tested on patient outcomes

The finding that only 0.2% of cleared AI devices have undergone evaluation for patient-centered outcomes reveals a profound validation gap and points to the need for evidence standards capable of keeping pace with the speed of regulatory clearance.

R. Abulibdeh, Sebastián Andrés Cajas Ordóñez, L. Celi et al. · 1 citation · ⚡1

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