Nearly Half of FDA-Approved AI Devices Not Based on Real Patient Data

Researchers urge FDA to require clinical validation for AI medical devices to ensure safety and effectiveness.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

Researchers from the University of North Carolina have called for more rigorous testing of artificial intelligence (AI)-powered medical devices, following a comprehensive study of nearly three decades of U.S. Food and Drug Administration (FDA) authorizations.

The study, published in Nature Medicine, found that nearly half of AI medical devices authorized by the FDA were not based on real patient data, raising concerns about their safety and effectiveness in real-world patient care.