950+ AI medical devices cleared — oversight still catching up
Abstract: Post-market monitoring standards for clinical AI tools remain unsettled as clearances accelerate.

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Problem
Over 950 AI-enabled medical devices are FDA-cleared, while post-market performance monitoring standards are still being defined.
Sources
- JournalismMedical Daily, 20262026-03-28
- Peer-reviewednpj Digital Medicine2025-05-31
- Peer-reviewedFrontiers in Mechanical Engineering2024-03-01
- Peer-reviewedActa Polytechnica Hungarica2023-01-01
- Peer-reviewedApplied Sciences2026-01-10
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