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FDA Releases Public List of AI‑Enabled Medical Devices，Over 1,600 Products Listed！

Time：2026-09-08 11:07:52

The commercialization of AI‑powered medical devices is gaining strong momentum.

The U.S. Food and Drug Administration (FDA) officially maintains and publicly releases the AI‑Enabled Medical Devices List. This public database compiles AI‑enabled medical devices that have obtained U.S. marketing authorization. As of the latest update, the list contains 1,614 entries. Developers, hospitals and patients can access and download the data openly, offering a critical reference for global AI medical‑device regulation and overseas market expansion.

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https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

一、What Is This List For

Maintained by the FDA’s Digital Health Center of Excellence, this list serves as a public reference resource with three core objectives:

For digital‑health innovators: to understand the current market landscape and regulatory expectations of the FDA, supporting innovation.
For healthcare providers and patients: to improve transparency by identifying medical devices incorporating AI technologies.
To showcase AI‑enabled medical devices that have passed FDA pre‑market review.

Important Note：This list is not exhaustive.

Devices are primarily identified and included based on AI‑related terminology in public summaries of marketing authorizations and device classifications (referencing the FDA Digital Health and Artificial Intelligence Glossary). Authorized devices whose decision summaries have not yet been published will not appear immediately and will be added in subsequent updates.

Each listed device has fulfilled applicable FDA pre‑market requirements and undergone safety‑and‑effectiveness assessment, including evaluation of clinical‑study adequacy for intended use and technical characteristics. Each entry links directly to the FDA database for publicly available safety‑and‑effectiveness summaries. Files can be downloaded in CSV, Excel and XML formats for bulk research and analysis.

二、Key List Fields

The latest batch of cleared products shows that radiology remains the dominant segment for AI medical devices, covering a large number of AI tools for image segmentation, CT, ultrasound, mammography and orthopedics. Products also span neurology, cardiovascular care, gastroenterology‑urology, obstetrics‑gynecology and other disciplines. Submissions come from multinationals including Philips, Siemens, Fujifilm and Canon, numerous overseas start‑ups, as well as Chinese firms such as United Imaging.

三、LLM‑Based Medical Devices

As large‑language models (LLMs) and multimodal foundation models are deployed in healthcare, the FDA has outlined its next regulatory priority:

The FDA is exploring mechanisms to specifically tag medical devices built on foundation models, including large‑language models and multimodal architectures.

This tagging will help innovators, healthcare providers and patients readily recognize when a medical device contains LLM‑enabled functionality. Sponsors are encouraged to include relevant information within public summaries to facilitate future list enhancements.

This sends a clear signal: transparency regulation for generative‑AI and foundation‑model medical devices is advancing rapidly. Beyond safety‑and‑effectiveness evaluation, disclosing the use of large models will become a key regulatory requirement.

四、Implications for Chinese AI‑Medical‑Device Firms Targeting the U.S. Market

This list delivers high‑value insights for Chinese enterprises planning U.S. market access:

Predicate‑Device Sourcing：The 1,600+ cleared entries form a valuable predicate pool for 510(k) submissions. Enterprises may reference submission pathways, intended uses and product codes of comparable devices.

Understand Review Expectations：Review cleared products within your target segment to grasp the FDA’s current acceptance boundaries for AI algorithms.

Prioritize High‑Quality Public Summaries：Inclusion in the list depends on AI‑related keywords within public summaries. Complete public documentation for SaMD (Software as a Medical Device) submissions affects both public disclosure and list eligibility.

Prepare for Future Foundation‑Model Disclosure Rules：If your product integrates LLMs or multimodal foundation models, plan disclosure requirements in advance to align with upcoming FDA transparency mandates.

Background：This list sits within the FDA’s SaMD (Software as a Medical Device) regulatory framework. Supporting official guidance documents include Good Machine Learning Practice for Medical Device Development: Guiding Principles, Predetermined Change Control Plans for Machine Learning‑Enabled Medical Devices: Guiding Principles, and Transparency for Machine Learning‑Enabled Medical Devices: Guiding Principles. Together they build the full regulatory framework for AI‑enabled medical devices.

五、Closing Remarks

AI medical algorithms have moved beyond laboratory research into large‑scale commercial deployment. The FDA list acts both as a market scorecard and a regulatory weathervane.On one hand, AI‑medical‑device clearances keep rising, with robust adoption in medical imaging, cardiovascular care, orthopedics, gastroenterology and other fields. On the other hand, regulations are evolving fast — especially for generative AI. Transparency and clear model identification will emerge as new critical compliance considerations.

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