How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations

Abstract We reviewed 1016 FDA authorizations of AI/ML-enabled medical devices to develop a taxonomy capturing key variations in clinical and AI-related features. Quantitative image analysis remains the most common application, but its relative proportion has declined recently. Over 100 devices lever...

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Bibliographic Details
Main Authors: Rohan Singh, Monika Bapna, Abdul Rahman Diab, Emily S. Ruiz, William Lotter
Format: Article
Language:English
Published: Nature Portfolio 2025-07-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-025-01800-1
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