Bars over time
AI-Enabled Medical Devices Authorized by the FDA
AI-enabled medical devices cleared or approved for the U.S. market, per calendar year
Plays the chart through its history. Pauses are where the data set a record or moved most.
Continuation · the recent trend, flattening · 3 years
Faint bars: the projected periods. Whiskers: the range about two in three outcomes land in. A projection, not a promise.
FDA list of AI-enabled medical devices, by date of final decision (510(k), De Novo or premarket approval). FDA adds devices in batches and says the list is not exhaustive; the current year appears once complete.
How many medical devices that use artificial intelligence the FDA authorized each year. The count has climbed steeply since the mid-2010s, and most of the devices are reviewed by the radiology panel.
What this chart reads
- FDA AI-Enabled Medical Device Authorizations (Annual)as “Devices authorized”latest 2025-12-31
Sources
FDA AI-Enabled Medical Device Authorizations (Annual). Source: U.S. Food and Drug Administration, "Artificial Intelligence-Enabled Medical Devices" list (fda.gov/medical-devices/artificial-intelligence-enabled-medical-devices), read from the CSV the list page links. Palanor counts devices by Date of Final Decision. FDA website policies: "Unless otherwise noted, the contents of the FDA website (www.fda.gov) — both text and graphics — are not copyrighted. They are in the public domain and may be republished, reprinted and otherwise used freely by anyone without the need to obtain permission from FDA." Read weekly.
Charts are drawn from Palanor's signal library and recomputed from source data on every view. Transformations (changes, indexing, year-on-year rates) are Palanor's.