ArticleCureus2026
Three Decades of Food and Drug Administration Authorizations of Artificial Intelligence/Machine Learning-Enabled Medical Devices: Persistent Specialty Concentration and the Care-Delivery Gap (1995-2025).
Article in Cureus, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background The US Food and Drug Administration (FDA) maintains a public list of artificial intelligence (AI) and machine learning (ML)-enabled medical devices that have received marketing authorization. Prior published analyses examined this list at earlier time points and reported a marked dominance of radiology applications. Methodology We performed a longitudinal descriptive analysis of all 1,430 AI/ML-enabled medical device authorizations recorded by the FDA between September 1995 and December 2025 to characterize the cumulative growth, specialty distribution, and manufacturer concentration of authorized devices. Results The annual authorization volume increased from a mean of 1.8 per year between 1995 and 2014 to 264 per year between 2023 and 2025, with 331 authorizations recorded in 2025 alone. Devices reviewed by the FDA's Radiology panel accounted for 1,094 of 1,430 authorizations (76.5%), and the three most represented panels (Radiology, Cardiovascular, and Neurology) accounted for 90.6% of all authorizations. Several large clinical specialties were represented by very small numbers of authorized devices, including Pathology (n = 9, 0.6%), Microbiology (n = 6, 0.4%), and Obstetrics and Gynecology (n = 4, 0.3%). No authorizations were recorded under a psychiatry or behavioral health review panel. Of 740 unique companies, 502 (67.8%) had a single authorized device, while 13 (1.8%) companies accounted for 247 (17.3%) devices. Conclusions The cumulative regulatory record demonstrates rapid growth that has been concentrated in image-rich diagnostic specialties, with limited representation across many specialties that account for substantial clinical activity in the United States. These findings may inform policy discussions about where regulatory, infrastructure, and dataset investments are most needed to broaden the clinical scope of medical AI.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.