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Regulatory Trends in AI-enabled SaMDs

FDA authorisations of AI-enabled software as medical devices (SaMDs) have increased significantly. Over 50% of FDA authorisations have occurred since 2022 with the majority (76%)…


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Health Technology Insight


Regulatory Trends in AI-enabled SaMDs

FDA authorisations of AI-enabled software as medical devices (SaMDs) have increased significantly. Over 50% of FDA authorisations have occurred since 2022 with the majority (76%)…