Mint dentistry5/28/2023 ![]() ![]() Updates to this list: The FDA plans to update this list on a periodic basis based on publicly available information. Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information. This list is not meant to be an exhaustive or comprehensive resource of AI/ML-enabled medical devices. ![]() The FDA assembled this list by searching FDA’s publicly-facing information, as well as by reviewing information in the publicly available resources cited below (*) and in other publicly available materials published by the specific manufacturers. The FDA is providing this list of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area.Ĭontents of this list: This list contains publicly available information on AI/ML-enabled devices. Over the past decade, the FDA has reviewed and authorized a growing number of devices legally marketed (via 510(k) clearance, granted De Novo request, or approved PMA) with ML across many different fields of medicine-and expects this trend to continue. Interest in medical devices incorporating ML functionality has increased in recent years. One of the greatest potential benefits of ML resides in its ability to create new and important insights from the vast amount of data generated during the delivery of health care every day. ![]() With this update, the FDA has also added the ability to download the list as an Excel file.Īs technology continues to advance every aspect of health care, software incorporating artificial intelligence (AI), and specifically the subset of AI known as machine learning (ML), has become an important part of an increasing number of medical devices. Octoupdate: 178 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices were added to the list below. ![]()
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