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Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

October 19, 2023 update: 171 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices were added to the list below. Of those newly added to the list, 155 are devices with final decision dates between August 1, 2022, and July 30, 2023, and 16 are devices from prior periods identified through a refinement of methods used to generate this list. 

October 5, 2022 update: 178 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices were added to the list below. With this update, the FDA has also added the ability to download the list as an Excel file.

As 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. 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.

Interest in medical devices incorporating ML functionality has increased in recent years. 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.

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.

Contents of this list: This list contains publicly available information on AI/ML-enabled 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.

This list is not meant to be an exhaustive or comprehensive resource of AI/ML-enabled medical devices. Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information.

Updates to this list: The FDA plans to update this list on a periodic basis based on publicly available information. Send questions or feedback on this list to digitalhealth@fda.hhs.gov.

AI/ML-Enabled Medical Devices

Devices are listed in reverse chronological order by Date of Final Decision. To change the sort order, click the arrows in the column headings.

Use the Submission Number link to display the approval, authorization, or clearance information for the device in the appropriate FDA database. The database page will include a link to the FDA's publicly available information.