New resource for finding FDA-approved medical devices that incorporate AI
The FDA has set up an online list of approved tools and devices with built-in AI and/or machine learning capabilities.
As of Sept. 23, the resource supplies device and company names, dates of FDA approvals and other details on some 343 devices.
The list’s homepage is searchable and will be updated as information on new approvals is made publicly available.
The agency says the list is not comprehensive but is intended to “increase transparency about these devices and the FDA’s work in artificial intelligence and machine learning-enabled devices.”
FDA’s Digital Health Center of Excellence, which launched in 2020 under the agency’s Center for Devices and Radiological Health (CDRH), is overseeing and maintaining the list.
Click here to check it out.