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.
![Axial images from unenhanced calcium score cardiac CT (left) and curved planar reformation images from CT angiography (right) show that higher long-term exposure to air pollution is associated with greater coronary artery calcium and more obstructive coronary artery disease (CAD). Top row: Images in a 68-year-old male patient with higher 10-year mean ambient air pollution exposure (7.9 μg/m3 for particulate matter measuring ≤2.5 μm in diameter [PM2.5] and 17.4 parts per billion [ppb] for NO2) with extensive CAD (coronary artery calcium score [CACS] >1,000 and obstructive CAD [≥70% diameter stenosis]). Bottom row: Images in a 57-year-old female patient with lower 10-year mean ambient air pollution exposure (6.3 μg/m3 for PM2.5 and 4.6 ppb for NO2) with no CAD (CACS = 0 and no obstructive stenosis).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/06/hanneman.r6SMLzkezo.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
