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FDA Pledges New Guidance on AI-Powered Medical Devices as Epic Updates Users
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FDA Pledges New Guidance on AI-Powered Medical Devices as Epic Updates Users

August 25, 2026

Source Summary

The FDA announced plans to develop new guidance for regulating generative AI-powered medical devices. Epic Systems held its user conference (UGM) and provided updates to attendees.

Why it matters

FDA guidance on AI-powered medical devices establishes regulatory standards that affect how healthcare technology companies develop and deploy artificial intelligence in clinical settings.

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