AI in Healthcare

The latest on artificial intelligence transforming medicine

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regulationMedTech Dive

CDRH Director Tarver Signals More AI Guidance Is Coming

At an AAMI event, FDA device chief CDRH Director Tarver previewed more AI guidance, suggesting regulators are preparing additional rules for how AI-enabled medical devices should be assessed. The signal matters because the sector is moving from experimental enthusiasm into a phase where clearer expectations will shape product design and submission strategy.

FDAAI guidanceCDRHmedical devices

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