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Chart showing the number of AI/ML devices approved by FDA by year from 2012 to 2023

Doctors Wary of Medical AI Devices: U.S. regulatory system criticized for approving AI medical devices without transparency.

The United States’ regulatory regime may not be clear or flexible enough to ensure the safety of AI-powered medical devices. Physicians and other health professionals believe that U.S. regulators have approved AI-powered medical products without proper oversight or disclosure.

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