Bunkerhill Health Secures FDA Clearance for First AI Tool to Detect Mitral Annular Calcification

9 October 2025

Bunkerhill Health has received U.S. Food and Drug Administration (FDA) clearance for Bunkerhill MAC, the first artificial intelligence algorithm designed to detect and quantify mitral annular calcification (MAC) using routine, non-gated chest CT scans.

MAC is a condition where calcium builds up in the mitral valve ring, often discovered incidentally. It has been associated with increased cardiovascular risk, including higher rates of mortality and complications during structural heart procedures. Despite its clinical importance, MAC is frequently under-reported or not quantified on standard chest CTs. Bunkerhill MAC automates detection and measurement, providing consistent and scalable insights from scans already performed for non-cardiac purposes.

The algorithm was developed and validated using data from Bunkerhill’s multi-institutional research consortium of over 25 leading academic medical centres, with datasets from seven sites, including Emory University, Thomas Jefferson University, and the University of California, San Francisco (UCSF).

Bunkerhill MAC is integrated into Carebricks, the company’s AI platform for clinical reasoning. Carebricks enables health systems to apply AI-driven analysis, including FDA-cleared algorithms and large language models, across patient data while automating workflow steps to support clinical decision-making.

 

Source: prnewswire.com