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) - Cureus

Over 30 years, the FDA has approved AI-powered medical devices, but they're concentrated in certain medical specialties and haven't reached many care settings where patients actually need them. This gap means many people aren't benefiting from AI tools that could help diagnose and treat their conditions.