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

A new study published in Cureus examines three decades of FDA authorizations for artificial intelligence and machine learning-enabled medical devices from 1995 to 2025. The research highlights a persistent concentration of approvals in specific medical specialties, such as radiology and cardiology, while many other critical areas of care remain underserved. This imbalance suggests a widening gap between technological advancement and equitable access to AI-driven diagnostics and treatments across the healthcare system.

The study analyzed 200+ FDA authorizations, revealing that over 70% of approvals were concentrated in just five specialties. This trend raises concerns about the scalability of AI adoption in healthcare, particularly in primary care, emergency medicine, and underserved populations. The findings underscore the need for policy adjustments to encourage broader, more inclusive AI integration in medicine.

Researchers also noted that the pace of approvals has accelerated in recent years, reflecting growing industry and regulatory interest in AI applications. However, the study cautions that without targeted interventions, the care-delivery gap may persist, limiting the potential benefits of AI for patients and providers alike.