The June 2026 FDA inventory lists 1,524 authorized AI algorithms, including 1,163 in radiology. The governance committees that sort by specialty are missing out on a large part of the offer.
The FDA's updated inventory, stopped in June 2026, brings the number of AI algorithms authorized in the United States to 1,524. Radiology largely dominates with 1,163 entries; cardiology comes in second place, with 225 algorithms if we include cardiovascular imaging, 146 of which are explicitly classified under the label "cardiology".
After the countdown, the difficulty becomes organizational. Remote monitoring tools raise the question of the routing of alerts and the availability of the personnel who must respond to them. Imaging guidance aids require integration with modalities and workstations. Automated echocardiographic quantification modifies the work flow of sonographers.
One blind spot stands out in particular: governance committees that only track devices labeled "cardiology" are missing an entire slice of cardiovascular AI marketed through other platforms. Hence the recommendation for IT teams to require data flow diagrams that specify what goes in and out of each tool, rather than reasoning by declared specialty.
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