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FDA AI-Enabled Medical Devices by Specialty
AI-enabled devices authorized per year by the FDA review panel that led the review
Plays the chart through its history. Pauses are where the data set a record or moved most.
FDA list of AI-enabled medical devices, by date of final decision and lead review panel. Other: anesthesiology, gastroenterology-urology, hematology, pathology, ophthalmic, surgery and the rest.
Which medical specialties the FDA’s AI-enabled devices serve. Radiology accounts for most of them in every year; cardiology and neurology follow far behind.
What this chart reads
- FDA AI-Enabled Device Authorizations: Radiology (Annual)as “Radiology”latest 2025-12-31
- FDA AI-Enabled Device Authorizations: Cardiovascular (Annual)as “Cardiovascular”latest 2025-12-31
- FDA AI-Enabled Device Authorizations: Neurology (Annual)as “Neurology”latest 2025-12-31
- FDA AI-Enabled Device Authorizations: Other Specialties (Annual)as “All other specialties”latest 2025-12-31
Sources
FDA AI-Enabled Device Authorizations: Radiology (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.
FDA AI-Enabled Device Authorizations: Cardiovascular (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.
FDA AI-Enabled Device Authorizations: Neurology (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.
FDA AI-Enabled Device Authorizations: Other Specialties (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.