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medical devices

AI Governance Factsheets Vertical Market AI

Healthcare has 1,451 AI devices and one shifting rulebook.

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 Read more

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