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

Abstract

Abstract 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 article, we performed comprehensive analysis of 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 radiology specialty in the application of machine learning tools, attributed to the abundant data from routine clinical data. The study also reveals a reliance on the 510(k)-clearance pathway, emphasizing its basis on substantial equivalence and often bypassing the need for new clinical trials. Also, it notes an underrepresentation of pediatric- focused devices and trials, suggesting an opportunity for expansion in this demographic. Moreover, the geographical limitation of clinical trials, primarily within the United States, points to a need for more globally inclusive trails to encompass diverse patient demographics. This analysis not only maps the current landscape of AI/ML-Enabled Medical Devices but also pinpoints trends, potential gaps, and areas for future exploration, clinical trial practices, and regulatory approaches.

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