FDA Clears CT-Based AI Software for Evaluating Coronary Artery and Aortic Valve Calcium

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Bunkerhill Contrast CAC and Bunkerhill Contrast AVC AI-enabled software, which can be utilized for detection and quantification of coronary artery calcium (CAC) and aortic valve calcium (AVC) based on contrast-enhanced chest CT scans.

Developed in collaboration with clinicians from Emory University, MedStar Health, the University of California-San Francisco (UCSF) and other institutions, Bunkerhill Contrast CAC and Bunkerhill Contrast AVC may facilitate earlier detection of key cardiovascular findings, according to Bunkerhill Health, the developer of the AI software.

“Coronary artery and aortic valve calcification carry important implications for cardiovascular risk and disease progression,” said Alexander Sandhu, MD, MS, an associate professor in the Division of Cardiology at the University of California-Los Angeles (UCLA) David Geffen School of Medicine. “The ability to detect and quantify these highly actionable findings on contrast-enhanced routine chest CT scans creates new opportunities to capture clinically relevant information and improve quality of care from imaging that is already being performed at scale.”

Bunkerhill Health added that a new billing code and associated reimbursement via the Hospital Outpatient Prospective Payment System (OPPS) went into effect on April 1, 2026 for the use of AI assessment of CAC and AVC with chest CT scans.