The FDA encourages the development of innovative, safe, and effective medical devices, including devices that incorporate Artificial Intelligence and Machine Learning (AI/ML). 

The AI/ML-Enabled Medical Device List is a resource intended to identify AI/ML-enabled medical devices that are authorized for marketing in the United States. 

Contents of the AI-Enabled Medical Devices List:

• The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the device’s overall safety and effectiveness, which includes an evaluation of study appropriateness for the device’s intended use and technological characteristics.  
• The list provides a direct link to the FDA’s database entry of each listed medical device that incorporates AI/ML. The database entry contains releasable information such as summaries of safety and effectiveness. Note, the summaries are not all inclusive and do not include most of the information that may be submitted in an application. 
• The list is not a comprehensive resource of medical devices that incorporate AI/ML. Instead, the list includes medical devices that incorporate AI/ML across medical disciplines, primarily based on information provided in the summary descriptions of their marketing authorization document.

This list will continue to be updated periodically.

Send questions or feedback on this list to digitalhealth@fda.hhs.gov.

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AI/ML-Enabled Medical Devices List

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.

Download a CSV File   Download an Excel File   Save as XML File*

*To save the XML file, right click and save the file to your computer and open in the appropriate program.