Artificial intelligence (AI) software developer Zebra Medical Vision has received U.S. Food and Drug Administration (FDA) 510(k) clearance for HealthCCSng, an AI-based software application for analysis of coronary artery calcium (CAC) on nongated CT studies.
The software is designed to identify previously undetected cardiovascular disease and enable earlier preventative treatment. It categorizes patients into three risk categories based on the extent of CAC it has detected.
Importantly, HealthCCSng quantifies CAC as an incidental finding on commonly ordered nongated CT scans. CAC has usually been quantified on a cardiac-gated CT scan, which subjects patients to added radiation exposure, as well as increased costs; cardiac-gated CT studies are typically not covered by insurance companies, Zebra Medical said.
The software will enable integrated delivery networks and commercial payors to actively manage and stratify the health risk of their covered populations, according to the firm. Patients can then be placed on relevant care pathways to prevent or mitigate the chance of a future cardiac event, Zebra Medical said.
HealthCCSng, which previously received the CE Mark, is the eighth Zebra Medical AI application to receive FDA clearance.
![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)
