San Francisco-based Bunkerhill Health has received clearance from the U.S. Food and Drug Administration (FDA) for its AI algorithm for detecting and quantifying mitral annular calcification (MAC).
Called Bunkerhill MAC, the algorithm was designed to detect mitral annular calcification -- a chronic condition in which calcium deposits build up in the mitral valve ring -- on nongated chest CT scans performed for noncardiac indications. Often discovered incidentally, studies have linked MAC to increased cardiovascular risk, including higher rates of mortality and complications in structural heart procedures, Bunkerhill said.
The algorithm was developed and tested on data from a multi-institutional research consortium of more than 25 academic medical centers, the company added.
![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)
