Clinical Specialty Expansion of AI-Enabled and Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration From 1995 to 2025: Longitudinal Content Analysis.

Abstract

The US Food and Drug Administration (FDA) has authorized AI-enabled and machine learning (ML)-enabled medical devices since 1995 and maintains a public registry of these authorizations. Prior analyses report that radiology dominates this landscape, but whether that concentration has persisted, intensified, or begun to reverse across 3 decades, particularly since 2022, remains insufficiently characterized. This study aimed to (1) characterize the longitudinal growth of FDA-authorized AI/ML-enable