FDA Clears AI Algorithms to Evaluate Coronary and Aortic Valve Calcium on Contrast-Enhanced Chest CTs

Bunkerhill Health has received U.S. Food and Drug Administration (FDA) clearance for the first and only artificial intelligence (AI) algorithms that detect and quantify coronary artery calcium (CAC) and aortic valve calcium (AVC) on contrast-enhanced, routine non-gated chest CT scans. The authorization expands Bunkerhill’s previous clearances for non-contrast chest computed tomography (CT).

Besides the FDA clearances for Bunkerhill Contrast CAC and Bunkerhill Contrast AVC, the company scored a Centers for Medicare and Medicaid Services (CMS) new national billing code and associated payment under the Hospital Outpatient Prospective Payment System (OPPS) for algorithmic analysis of CAC and AVC on chest CT scans.

Bunkerhill Health initiated and led the CMS submission through the New Technology APC pathway and engaged directly with the agency throughout the process, supporting the establishment of this billing pathway for AI-enabled cardiovascular analysis, including detailed technical review and discussion of the underlying AI technology. Establishing a national reimbursement pathway provides a clearer framework for the way AI-based cardiovascular analysis can be evaluated and supported in clinical practice.

“Establishing a reimbursement pathway is an important step toward broader adoption of AI in clinical care,” Bunkerhill Health Co-Founder/CEO Nishith Khandwala stated. “We worked closely with CMS to help define how this technology can be evaluated and supported in practice. With this pathway in place, health systems have greater clarity on how to incorporate AI-driven insights into clinical workflows in appropriate clinical contexts to help identify and manage patients with meaningful cardiovascular findings.”

Millions of patients undergo chest CT scans each year, including both contrast-enhanced and non-contrast studies performed for a wide range of clinical indications. Establishing a national reimbursement pathway supports the use of AI to detect and quantify CAC and AVC on these routine scans, enabling earlier identification of patients with clinically significant cardiovascular findings.

Bunkerhill Contrast CAC and Bunkerhill Contrast AVC extend Bunkerhill’s existing non-contrast chest CT capabilities to contrast-enhanced routine chest CT scans, enabling automated identification and quantification of these findings on scans patients already receive as part of routine care.

“Coronary artery and aortic valve calcification carry important implications for cardiovascular risk and disease progression,” said Alexander Sandhu, M.D., associate professor in the Division of Cardiology at the University of California, Los Angeles, 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.”

The algorithms were developed with academic medical centers in Bunkerhill’s research consortium, including UCSF, Emory University, and MedStar Health. This multi-institutional effort enabled the algorithms’ development and validation across diverse clinical environments.

Bunkerhill Contrast CAC and Bunkerhill Contrast AVC are available within Carebricks, Bunkerhill’s AI platform that enables clinical and operational teams at health systems to build and deploy AI agents that bring their ideas to life. Carebricks allows health systems to design AI agents that reason across a patient’s full medical history using LLMs and FDA-cleared algorithms. These agents can then execute the actions defined by clinicians and operational teams, such as initiating referrals, coordinating follow-up care, sending patient and provider notifications, placing orders, and completing tasks across third-party systems.

The clearances expand Bunkerhill’s portfolio of FDA-cleared algorithms and its work with health systems to operationalize new ideas across care delivery.

Bunkerhill Health works with health systems and hospitals to help operationalize their ideas.