Bunkerhill Health has received approval from the U.S. Food and Drug Administration (FDA) for Bunkerhill MAC, an artificial intelligence (AI) tool designed to detect and measure mitral annular calcification (MAC). The algorithm works with standard, non-gated chest CT scans.
Mitral annular calcification is a condition in which calcium builds up around the mitral valve. While it is often found by chance, research has linked MAC to higher cardiovascular risk and increased complications during structural heart procedures.
Despite its importance, MAC is not always measured or reported consistently on routine CT scans. Bunkerhill MAC addresses this gap by automatically identifying and quantifying MAC from scans already performed for other purposes, providing more consistent and widespread detection.
The AI was developed using data from a research consortium of more than 25 leading academic medical centres. For FDA clearance, data from seven consortium sites, including Emory University, Thomas Jefferson University, and the University of California, San Francisco, were used. This represents one of the largest academic collaborations applied to an FDA-cleared AI tool.
Bunkerhill MAC is available via Carebricks, Bunkerhill’s AI platform for clinical decision support. The platform integrates FDA-approved algorithms and AI reasoning tools to analyse patient data and support automated clinical workflows.
With FDA approval, Bunkerhill MAC allows clinicians to detect and measure MAC at scale using routine CT scans, helping to assess cardiovascular risk and guide patient care within existing clinical workflows.
