Three Decades of FDA Authorizations of AI/ML Enabled Medical Devices: Persistent Specialty Concentration and the Care Delivery Gap (1995 to 2025)

The US Food and Drug Administration (FDA) maintains a public list of artificial intelligence and machine learning (AI/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. We performed a cross-sectional analysis of all 1,430 AI/ML-enabled medical device authorizations recorded by the FDA between September 1995 and December 2025 to characterize the cumulative growth, specialty distribution, and manufacturer concentration of authorized devices. The annual authorization volume increased from a mean of 1.8 per year between 1995 and 2014 to 264 per year b