The FDA has authorized more AI-enabled medical devices than any other regulator in the world. The rules governing how they are updated, disclosed, and monitored are being rewritten in real time, and not always in the direction of stronger oversight.
- 1,451: FDA-authorized AI/ML devices, cumulative through Dec 2025
- 76%: Share concentrated in radiology imaging
- 295: New authorizations in calendar year 2025, a record
- 0: Generative-AI or LLM-powered devices authorized to date
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