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-d

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ethics.ai (24 January 2024), “FDA-Approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices: An Updated Landscape,” evidence record 9554, https://ethics.ai/record/9554 (originally published by OpenAlex).

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