Regulatory Horizons: AI & Digital Health – FDA Evolving Oversight episode artwork

EPISODE · Jan 7, 2026 · 35 MIN

Regulatory Horizons: AI & Digital Health – FDA Evolving Oversight

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Today we will focus our discussion on AI and Digital Health and FDA’s Evolving Oversight. The FDA has been actively shaping its regulatory framework for AI and machine learning in medical devices, recognizing that traditional device regulations were designed for static products not adaptive algorithms that learn over time.Questions and Comments: [email protected], [email protected], [email protected]

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Regulatory Horizons: AI & Digital Health – FDA Evolving Oversight

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This episode was published on January 7, 2026.

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Today we will focus our discussion on AI and Digital Health and FDA’s Evolving Oversight. The FDA has been actively shaping its regulatory framework for AI and machine learning in medical devices, recognizing that traditional device regulations were...

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