Bunkerhill wins FDA clearance for calcium AI on contrast chest CT

Bunkerhill Health has received U.S. Food and Drug Administration clearance for 2 AI algorithms designed to detect and quantify calcium on non-gated, contrast-enhanced chest CT scans.

Bunkerhill Contrast CAC detects and quantifies coronary artery calcium, while Bunkerhill Contrast AVC detects and quantifies aortic valve calcium. The company said the clearances extend its existing capabilities for non-contrast chest CT to contrast-enhanced routine chest CT scans.

FDA 510(k) records for Bunkerhill Contrast AVC state that the software is intended for adult patients 40 years and older. It automatically analyzes non-gated, contrast-enhanced chest CT images collected during clinical care and outputs a region of interest and calcium quantification.

Separately, CMS established HCPCS code G0680 for algorithmic analysis of coronary artery calcium and/or aortic valve calcium from chest CT with report. The code became effective April 1 under the Hospital Outpatient Prospective Payment System.

The company said it led the CMS submission through the New Technology APC pathway. Bunkerhill described the reimbursement pathway as a way for hospitals to bill for AI-based calcium analysis on chest CT scans.

Development involved collaborations with the University of California, San Francisco, Emory University, and MedStar Health, according to the announcement. The algorithms are available through Carebricks, Bunkerhill’s AI platform for health systems.