Physician AI Tools vs the FDA AI Device List
The FDA's list is the official record of AI-enabled medical devices authorized for marketing in the United States, and it is the right place to confirm a device's authorization. Physician AI Tools is a directory for choosing between tools: it adds specialty, HIPAA posture, EHR integration, pricing, company and investor details, and it also covers medical software that is not a regulated device, such as AI scribes. Use the FDA list to confirm, and Physician AI Tools to compare.
| Physician AI Tools | The FDA AI device list | |
|---|---|---|
| Focus | Medical AI only: tools, the companies that make them and the investors behind them. | AI-enabled medical devices that are authorized for marketing in the United States. |
| Filter by medical specialty | Yes. Browse and filter tools by physician specialty. | Each device shows its lead review panel, such as Radiology or Cardiovascular, and the columns can be sorted. A filter is not stated. |
| FDA clearance status | Shown on each tool and usable as a filter. Each compliance detail is labelled by where it came from: the vendor, an FDA record, or an AI estimate. | Every entry is an authorized device, with the date of the final decision and a submission number that links to the FDA database record. |
| HIPAA and EHR integration filters | Filters for HIPAA posture and for EHR integration. | Not among the fields on the list. |
| Company and investor data | Company profiles (country, funding, products) and investor profiles (stage, check size, focus), linked to each other and to the tools. | The company name for each device. Investors and funding are not among the fields. |
| Who writes the listings and how they are checked | Profiles are researched from each product's own website and public FDA records, with AI assistance. Vendors can claim and edit their profile. New submissions are reviewed by our team before they go live. | The FDA. Devices are identified mainly from AI-related terms in the summary of each marketing authorization, and the list is updated periodically. |
| Cost to list a tool | Free. Optional paid placements start at $99 a month and are labelled as sponsored. | It is not a listing service. A device appears after FDA marketing authorization. |
| Cost to browse | Free. No account needed. | A public web page, with CSV and Excel downloads. |
Details about the FDA AI device list are from its own public pages, checked 11 November 2026: FDA: List of Artificial Intelligence-Enabled Medical Devices, FDA: Artificial Intelligence-Enabled Medical Devices. "Not stated" means those pages do not say.
Choose the FDA AI device list if
- You need to confirm that a specific device is FDA authorized, from the official source.
- You want the submission number and the FDA database record for a device.
- You are researching the whole field of authorized AI devices and want the data as a spreadsheet.
- You need a regulator's record for a compliance, legal or academic purpose.
Choose Physician AI Tools if
- You are choosing between tools and need more than authorization status: specialty fit, HIPAA posture, EHR integration and pricing.
- You are looking at medical software that is not a regulated device, such as an AI scribe, coding or scheduling tool.
- You want to know who makes a tool and who has invested in the company.
- You want one page per tool that you can share with a colleague.
Who Physician AI Tools suits most
A physician or practice leader who has to pick a tool, not study the market. You want to start from your specialty, see which tools are FDA cleared and which are not regulated devices at all, and check that a tool works with your EHR. When a profile cites an FDA record, you can follow it back to the FDA's own database to confirm.
Questions
Is the FDA list or Physician AI Tools the official source for FDA status?
The FDA. Its list and database are the official record of device authorization. Physician AI Tools shows FDA status to help you compare tools and labels where each detail came from, so always confirm an authorization with the FDA.
Does the FDA list include AI scribes and billing software?
The FDA's list covers AI-enabled medical devices that it has authorized for marketing. The FDA explains that it regulates medical devices, not AI as such. Physician AI Tools also lists medical software that is not a regulated device.
Can I filter the FDA list by specialty?
Each device on the FDA list shows a lead review panel, such as Radiology, and you can sort the columns or download the list as a spreadsheet. Physician AI Tools lets you browse and filter by physician specialty directly.
Does the FDA list show HIPAA, EHR integration or pricing?
No. Those are not among the fields on the list, which records the decision date, submission number, device, company, panel and product code. Physician AI Tools adds HIPAA posture, EHR integration and pricing where they are known.
How should I use the two together?
Use Physician AI Tools to find and compare the tools that fit your specialty and EHR, then confirm the authorization of any device you are serious about in the FDA's own record.