Three Decades of FDA Authorizations of AI/ML Enabled Medical Devices: Persistent Specialty Concentration and the Care Delivery Gap (1995 to 2025)
This cross-sectional analysis of 1,430 FDA authorizations from 1995 to 2025 reveals that while AI/ML-enabled medical device approvals have surged exponentially, they remain heavily concentrated in image-rich diagnostic specialties like radiology, leaving significant gaps in representation for other major clinical fields such as pathology, obstetrics, and behavioral health.