FDA AI-Enabled Medical Devices List Reaches 1,614 Entries
The U.S. Food and Drug Administration, FDA, maintains an AI-Enabled Medical Devices List to identify AI-enabled medical devices that are authorized for marketing in the United States.
The FDA states that the list is intended to help digital health innovators understand the current device landscape and regulatory expectations, while also providing transparency for healthcare providers and patients when medical devices use AI technologies.
Purpose of the List
According to the FDA, the list includes devices that have met applicable premarket requirements.
This includes a focused review of the device’s overall safety and effectiveness, including evaluation of study appropriateness for the device’s intended use and technological characteristics.
The list also provides direct links to FDA database entries, where releasable information may be available, including summaries of safety and effectiveness.
Not a Comprehensive Resource
The FDA notes that the list is not a comprehensive resource of all AI-enabled medical devices.
Instead, devices are identified primarily based on the use of AI-related terms in the summary descriptions of marketing authorization documents and/or device classifications. The FDA states that the AI terms are based on its Digital Health and Artificial Intelligence Glossary.
Focus on Foundation Models and LLMs
To support transparency in the use of modern AI technologies, the FDA states that it will explore methods to identify and tag medical devices that incorporate foundation models, including systems such as large language models, LLMs, and multimodal architectures.
The FDA explains that this identification will help innovators, healthcare providers and patients recognize when LLM-based functionality is present in a medical device. Sponsors are encouraged to include appropriate information in their public summaries to support future identification of such devices.
Periodic Updates
The FDA states that the list will continue to be updated periodically.
AI-enabled medical devices that have received authorization but whose decision summaries have not yet been published within the data collection period will be incorporated into a later update.
List Structure
The FDA explains that devices are listed in reverse chronological order by Date of Final Decision.
Users can use the submission number link to access approval, authorization or clearance information in the relevant FDA database. The page also includes options to download the list as CSV, Excel or XML.
Latest Entries Shown
The table shown in the uploaded page includes recent entries from June 2026, including devices such as Auto-Seg (SO-0012), Spine, ADAS 3D, Alturion Series Diagnostic Ultrasound System, SOMNUM, MammoScreen® (5) and several radiology, neurology, cardiovascular, anesthesiology and gastroenterology/urology devices.
The table displayed on the page shows 1,614 entries in total.
Impact on Medical Device and Digital Health Stakeholders
For medical device manufacturers, software developers, AI developers, digital health companies and regulatory teams, the FDA list is important because it provides a public view of AI-enabled devices that have received FDA marketing authorization.
Stakeholders should pay particular attention to:
AI-enabled device authorization trends;
device panels and product codes;
FDA database links and public summaries;
intended use and technological characteristics;
transparency expectations for AI-enabled devices;
future identification of foundation model and LLM-based functionality;
public summary content for AI-related features;
competitive landscape monitoring;
regulatory strategy for AI-enabled medical devices.
For companies developing AI-enabled medical devices, the key message is that FDA continues to support innovation while emphasizing safety, effectiveness, transparency and clear identification of AI technologies used in medical devices.
