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Published on in Vol 28 (2026)

Person using a smartphone to monitor a continuous glucose monitor (CGM) on their arm.

The US Food and Drug Administration’s TEMPO Pilot Signals a New Regulatory Approach for AI-Enabled Medical Devices

The US Food and Drug Administration’s TEMPO Pilot Signals a New Regulatory Approach for AI-Enabled Medical Devices

Authors of this article:

Tejas S Athni, JMIR Correspondent

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