Bo-Young Youn

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 Background 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, inten...