Bunkerhill Health has received U.S. Food and Drug Administration (FDA) clearance for two AI algorithms for use with contrast-enhanced, non-gated chest CT scans.
Bunkerhill Contrast CAC and Bunkerhill Contrast AVC are designed to detect and quantify coronary artery calcium (CAC) and aortic valve calcium (AVC), according to the firm. It said the algorithms are the first cleared for this application on contrast-enhanced studies, expanding its prior clearances for non-contrast chest CT.
Separately, the U.S. Centers for Medicare and Medicaid Services (CMS) has established a new national billing code and associated payment under the Hospital Outpatient Prospective Payment System (HOPPS) for algorithmic CAC and AVC analysis on chest CT, effective April 1, 2026. Bunkerhill said it led the submission to CMS through the New Technology APC pathway.
The algorithms were developed in collaboration with UCSF, Emory University, and MedStar Health and are available within Carebricks, Bunkerhill's AI platform for health systems, the company noted.
