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FDA Approval of Artificial Intelligence and Machine Learning Devices in Radiology

JAMA Network Open 10.1001/jamanetworkopen.2025.42338

November 07, 2025 at 11:00 AM EST

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This sytematic review examines US Food and Drug Administration (FDA) premarket clearances for artificial intelligence and machine learning devices in radiology with emphasis on testing.

Corresponding Author: Ram Sivakumar, MD, Washington University in St Louis, 510 S Kingshighway Blvd, St Louis, MO 63110 (rams@wustl.edu).

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