FDA clears Bunkerhill chest CT AI algorithms
The clearances cover AI tools for coronary artery calcium and aortic valve calcium analysis on contrast-enhanced, routine non-gated chest CT scans.
Bunkerhill Health has received FDA clearance for 2 AI algorithms designed for contrast-enhanced, routine non-gated chest CT scans. Bunkerhill Contrast CAC and Bunkerhill Contrast AVC detect and quantify coronary artery calcium and aortic valve calcium, according to the company.
Company statements describe the algorithms as the first FDA-cleared tools for CAC and AVC analysis on contrast-enhanced chest CT studies. Bunkerhill said the clearances expand its prior approvals for non-contrast chest CT.
CMS also established a national billing code for software analysis of coronary artery calcium and aortic valve calcification from chest CT scans. The April 2026 OPPS update lists HCPCS code G0680 for the procedure.
Effective April 1, 2026, the code carries an associated payment under the Hospital Outpatient Prospective Payment System. Bunkerhill said it led the submission through the New Technology APC pathway.
Carebricks, Bunkerhill’s AI platform for health systems, hosts the algorithms. The company said the platform allows health systems to deploy AI agents that combine FDA-cleared algorithms with broader patient history.
Development involved collaborators from UCSF, Emory University, and MedStar Health.
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