Bunkerhill Health Receives FDA Clearance for the First-Ever AI Solution to Detect Mitral Annular Calcification

SAN FRANCISCO, Oct. 8, 2025 /PRNewswire/ -- Bunkerhill Health today announced that it has received U.S. Food and Drug Administration (FDA) clearance for Bunkerhill MAC, the first artificial intelligence algorithm to detect and quantify mitral annular calcification (MAC). The algorithm runs on routine, non-gated chest CT scans.

MAC is a chronic condition in which calcium deposits build up in the mitral valve ring. Although often discovered incidentally, studies have linked MAC with increased cardiovascular risk, including higher rates of mortality and complications in structural heart procedures. Despite its significance, MAC is often not quantified or consistently reported on routine chest CTs. By automatically identifying and quantifying MAC on the chest CT scans patients already receive for non-cardiac indications, Bunkerhill MAC brings consistency and scale to an overlooked but important finding.

The algorithm was developed and tested using data from Bunkerhill's multi-institutional research consortium of 25+ leading academic medical centers. For this clearance, data from seven consortium sites were included, among them Emory University, Thomas Jefferson University and the University of California, San Francisco (UCSF). This clearance represents one of the broadest academic collaboration efforts yet applied to the development of an FDA-cleared AI algorithm.

Bunkerhill MAC is available within Carebricks, Bunkerhill's AI platform for clinical reasoning and action. Carebricks allows health systems to apply AI-powered reasoning — including LLMs and FDA-cleared algorithms — across the full scope of patient data and to customize workflows that automate appropriate next steps.

"FDA clearance of this algorithm is a landmark not just for Bunkerhill, but for how we use routine data to advance cardiac care," said Nishith Khandwala, co-founder and CEO of Bunkerhill Health. "By making MAC quantification available at scale through routine CT scans, we're giving clinicians a new tool to better understand risk and tailor patient care, all embedded seamlessly into the workflows they already use."

About Bunkerhill Health
Bunkerhill Health delivers generative AI for clinical reasoning and action. Its flagship platform, Carebricks, analyzes structured and unstructured patient data to understand each patient's full history, apply AI-powered reasoning across all available context and automate next steps. Carebricks helps health systems improve outcomes, increase efficiency and close care gaps without adding to clinician workload. Learn more at bunkerhillhealth.com.

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SOURCE Bunkerhill Health