FDA-Approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices: An Updated Landscape

As artificial intelligence (AI) has been highly advancing in the last decade, machine learning (ML)-enabled medical devices are increasingly used in healthcare. In this study, we collected publicly available information on AI/ML-enabled medical devices approved by the FDA in the United States, as of the latest update on 19 October 2023. We performed comprehensive analysis of a total of 691 FDA-approved artificial intelligence and machine learning (AI/ML)-enabled medical devices and offer an in-depth analysis of clearance pathways, approval timeline, regulation type, medical specialty, decision type, recall history, etc. We found a significant surge in approvals since 2018, with clear dominance of the radiology…