Three Decades of Food and Drug Administration Authorizations of Artificial Intelligence/Machine Learning-Enabled Medical Devices: Persistent Specialty Concentration and the Care-Delivery Gap (1995-2025).

Abstract

Background The US Food and Drug Administration (FDA) maintains a public list of artificial intelligence (AI) and machine learning (ML)-enabled medical devices that have received marketing authorization. Prior published analyses examined this list at earlier time points and reported a marked dominance of radiology applications. Methodology We performed a longitudinal descriptive analysis of all 1,430 AI/ML-enabled medical device authorizations recorded by the FDA between September 1995 and Decemb