FDA approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices: An updated 2022 landscape

Abstract As artificial intelligence (AI) has been highly advancing in the last decade, machine learning (ML) based medical devices are increasingly used in healthcare. In this article, we did an extensive search on FDA database and performed analysis of FDA approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. We have presented all the listed AI/ML-Enabled Medical Devices according to the date of approval, medical specialty, implementation modality of Medical Devices, and anatomical site of use. Our summary includes the current landscape of FDA approved AI/ML-Enabled Medical Devices till date and different FDA approval pathways for medical devices which will help understand the overview of AI/ML-Enabled Medical Devices, and its overall trends.