Bunkerhill AI for Calcium on Contrast Chest CT Cleared as CMS Adds Billing Code
The company announced two FDA 510(k) clearances alongside a new Medicare outpatient payment code for AI analysis of coronary and aortic valve calcium.

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.
Key points
- FDA records show 510(k) clearances on March 6, 2026, for Bunkerhill Contrast CAC (K260166) and Bunkerhill Contrast AVC (K260167); the company announced them on April 15.
- Bunkerhill says the algorithms detect and quantify coronary artery and aortic valve calcium on contrast-enhanced, routine non-gated chest CT scans.
- The company said CMS created a national billing code under the hospital outpatient payment system, effective April 1, for algorithmic analysis of such calcium on chest CT.
Bunkerhill Health announced on April 15 that the U.S. Food and Drug Administration has cleared two AI algorithms that detect and quantify calcium in the heart's arteries and aortic valve on contrast-enhanced chest CT scans, and that Medicare has created a national billing code for that kind of analysis, as reported by HIT Consultant.
FDA database entries show that Bunkerhill Contrast CAC (K260166) and Bunkerhill Contrast AVC (K260167) were both received on January 20, 2026, and found substantially equivalent on March 6, 2026. Both are listed under regulation number 892.1750, the classification for computed tomography X-ray systems.
What the algorithms do
According to the company, the two products are the first AI algorithms cleared to detect and quantify coronary artery calcium (CAC) and aortic valve calcium (AVC) on contrast-enhanced, routine non-gated chest CT scans. Bunkerhill said that extends its earlier clearances for non-contrast imaging, so the analysis can run on a wider range of scans that are already performed for other reasons.
"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," said Alexander Sandhu, an associate professor of cardiology at the UCLA David Geffen School of Medicine, in the company announcement as carried by HLTH.
The algorithms were developed with academic partners including UCSF, Emory University and MedStar Health, the company said. They are deployed through Carebricks, Bunkerhill's AI platform, which HIT Consultant reported lets health systems set up AI agents that can start cardiology referrals, coordinate follow-up care and message providers when the software finds significant calcium.
New Medicare payment code
Bunkerhill said that, effective April 1, 2026, the Centers for Medicare and Medicaid Services established a national billing code and payment under the Hospital Outpatient Prospective Payment System for algorithmic analysis of CAC and AVC on chest CT scans. The company said it led the submission through the New Technology APC pathway and worked directly with CMS on how such analyses can be evaluated and paid for.
"Establishing a reimbursement pathway is an important step toward broader adoption of AI in clinical care," said Nishith Khandwala, Bunkerhill's co-founder and chief executive. "We worked closely with CMS to help define how this technology can be evaluated and supported in practice."
The announcement did not state the payment amount attached to the new code or how many health systems use Carebricks.
Sources
- CMS Establishes New Billing Code for AI-Driven Calcium Analysis on CT Scans, HIT Consultant, April 15, 2026
- 510(k) Premarket Notification K260166: Bunkerhill Contrast CAC, FDA, March 6, 2026
- 510(k) Premarket Notification K260167: Bunkerhill Contrast AVC, FDA, March 6, 2026
- Bunkerhill Health Secures CMS Reimbursement and FDA Clearance for AI Cardiovascular CT Analysis, HLTH, April 16, 2026