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businessMar 26, 2025pending

Reading the Tea Leaves in FDA's AI-Enabled Device Guidelines

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While recent draft guidance from the Food and Drug Administration on artificial intelligence-enabled medical devices is non-binding, the document signals that the agency is intensifying its regulatory scrutiny of these technologies, said Dr. Scott Schell of IT consulting firm Cognizant.

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Reading the Tea Leaves in FDA's AI-Enabled Device Guidelines

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