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TRV-2026-0013Version 5 · Sources changed

Written 2026-07-12 20:50:53 UTC · current record

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TRUVACE RECORD VERSION
record: TRV-2026-0013
version: 5
kind: sources_changed
reason: Source set updated
timestamp: 2026-07-12T20:50:53.417576Z
status: published
lens: p_space
sector: policy
headline: 950+ AI medical devices cleared — oversight still catching up
dek: Post-market monitoring standards for clinical AI tools remain unsettled as clearances accelerate.
gain_reading: (none)
problem_reading: Over 950 AI-enabled medical devices are FDA-cleared, while post-market performance monitoring standards are still being defined.
limitation: Clearance counts alone do not measure patient harm; the gap is in monitoring, which means harms may be going unrecorded rather than not occurring.
tag: Oversight gap
key_points: (none)
rundown: (none)
sources:
- peer_reviewed | Acta Polytechnica Hungarica | https://doi.org/10.12700/aph.20.8.2023.8.15 | 2023-01-01
- peer_reviewed | Applied Sciences | https://doi.org/10.3390/app16020728 | 2026-01-10
- peer_reviewed | Frontiers in Mechanical Engineering | https://doi.org/10.3389/fmech.2024.1353108 | 2024-03-01
- peer_reviewed | npj Digital Medicine | https://doi.org/10.1038/s41746-025-01717-9 | 2025-05-31
- journalism | Medical Daily, 2026 | https://www.medicaldaily.com/ | 2026-03-28
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