40 of the 1,614 devices on the FDA's AI-Enabled Medical Device List were authorized through a De Novo grant, by Kent Applied's count.
40
of the 1,614 devices on the FDA's AI-Enabled Medical Device List were authorized through a De Novo grant
40 of the 1,614 devices on the FDA's AI-Enabled Medical Device List were authorized through a De Novo grant, by Kent Applied's count.
The FDA describes De Novo as "a marketing pathway to classify novel medical devices" for which "there is no legally marketed predicate device."
Sources: FDA, Artificial Intelligence-Enabled Medical Devices (opens in a new tab), The list (CSV), content current as of September 4, 2026: Date of Final Decision, Submission Number, Panel (Lead), Primary Product Code; FDA, De Novo Classification Request (opens in a new tab), First paragraph. Verified October 2026.
Related charts
- From research
40 devices on the FDA's AI list came through De Novo grants, each a new device type
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, product classification file; FDA, De Novo Classification Request - From research
About one FDA 510(k) clearance in ten is now for a device on the AI list
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, 510(k) releasable files - From research
More than half of the FDA's 2025 clearances tagged radiology were for AI-listed devices
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, 510(k) releasable files - From research
Three in four AI-listed devices are in the radiology panel; its share peaked in 2020
FDA, Artificial Intelligence-Enabled Medical Devices
Sources for the figures above: FDA, De Novo Classification Request (opens in a new tab).
Related facts
76.2%
of the 1,614 devices on the FDA's AI-Enabled Medical Device List are listed under its radiology panel
Radiology is the lead panel for 1,230 of the 1,614 devices on the FDA's AI-Enabled Medical Device List (76.2%), in the version current as of September 4, 2026, by Kent Applied's count.
Source: FDA, Artificial Intelligence-Enabled Medical Devices.
KentApplied54.0%
of the 510(k) clearances tagged with the FDA's radiology review committee in 2025 were for devices on its AI list
In 2025, 252 of the 467 510(k) clearances tagged with the FDA's radiology review committee (54.0%) were for devices on the FDA's AI-Enabled Medical Device List, by Kent Applied's count.
Source: FDA, Artificial Intelligence-Enabled Medical Devices.
KentApplied408
of the 1,614 devices on the FDA's AI-Enabled Medical Device List are filed under a scanner's product code
408 of the 1,614 devices on the FDA's AI-Enabled Medical Device List (25.3%) are filed under the product code of a scanner, such as an ultrasound, CT or MRI system, by Kent Applied's grouping of 18 FDA product codes.
Source: FDA, Artificial Intelligence-Enabled Medical Devices.
KentApplied
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