Healthcare is where AI's progress is easiest to count — because every clinical AI tool clears a regulator. The trend line is steep.
The numbers
- As of July 2025, the FDA lists 1,250+ AI-enabled medical devices — up from ~950 in August 2024.
- Clearances are up roughly 350% in five years.
- Radiology dominates, then cardiology and neurology. Median clearance time in 2025: 142 days.
What's actually shipping
Approved devices are overwhelmingly assistive, not autonomous — flagging abnormalities for a radiologist to confirm, guiding a surgeon, supporting bedside evaluation. A human stays in the decision, by design and regulation.
Healthcare AI advances at the speed of evidence and oversight. That's not a brake on innovation — it's what makes it trustworthy.
The FDA's Predetermined Change Control Plan — pre-authorising how a model may evolve after clearance — is a preview of how every regulated industry will handle software that learns.
Sources
- IntuitionLabs — FDA AI/ML medical device tracker
- Stanford HAI — 2025 AI Index
Written by ivector
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