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FDA updates list of approved AI/ML-enabled medical devices

Last week, the U.S. Food and Drug Administration (FDA) updated a list maintained by the agency of cleared artificial intelligence and machine learning (AI/ML)-enabled medical devices. The FDA added 178 devices that have now been cleared to be marketed in the United States. There are now 521AI/ML-enabled devices authorized by FDA on the list, with some approvals going back decades. The first device listed had its authorization date in 1995. The vast majority of the authorized devices are in the radiology space.

These devices are now legally marketed after the FDA's scientific and regulatory approval [via 510(k) clearance, granted De Novo request, or via premarket approval (PMA)]. The FDA publishes this list of AI/ML-enabled medical devices marketed in the US as a resource to the public about these devices and the FDA’s work in this area. The listing displays the approval, authorization, or clearance information for each AI/ML-enabled device with links to the FDA's publicly available information.

The FDA plans to continue to update the list on an ongoing basis.

This list is not meant to be an exhaustive or comprehensive resource of AI/ML-enabled medical devices. Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information.

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health care & life sciences, diagnostic radiology, ai

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