A longitudinal descriptive analysis of all 1,430 AI/ML-enabled medical device authorizations recorded by the US Food and Drug Administration between September 1995 and December 2025 found that annual authorization volume increased from a mean of 1.8 per year between 1995 and 2014 to 264 per year between 2023 and 2025, with 331 authorizations recorded in 2025 alone. Devices reviewed by the FDA’s Radiology panel accounted for 1,094 of 1,430 authorizations (76.5%), and the three most represented panels (Radiology, Cardiovascular, and Neurology) accounted for 90.6% of all authorizations. Several large clinical specialties had very small numbers of authorized devices, including Pathology (n = 9, 0.6%), Microbiology (n = 6, 0.4%), and Obstetrics and Gynecology (n = 4, 0.3%), with no authorizations recorded under a psychiatry or behavioral health review panel. Of 740 unique companies, 502 (67.8%) had a single authorized device, while 13 (1.8%) companies accounted for 247 (17.3%) devices. The authors concluded that the cumulative regulatory record demonstrates rapid growth concentrated in image-rich diagnostic specialties, with limited representation across many specialties that account for substantial clinical activity in the United States.