FDA OKs 1st AI Algorithm to Detect Mitral Annular Calcification

Bunkerhill Health has obtained U.S. Food and Drug Administration (FDA) clearance for Bunkerhill MA, the first artificial intelligence (AI) algorithm to detect and quantify mitral annular calcification (MAC). The algorithm runs on routine, non-gated chest CT scans.

MAC is a chronic condition where calcium deposits build up in the mitral valve ring. It’s often discovered incidentally, but studies have linked MAC with higher cardiovascular risk—including elevated rates of mortality and complications in structural heart procedures.

Despite this, MAC isn’t often quantified or consistently reported on routine chest CTs. Bunkerhill MAC addresses this by automatically identifying and quantifying MAC on chest CT scans that patients already get for non-cardiac indications.

The algorithm was built and tested using data from the company’s multi-institutional research consortium of over 25 academic medical centers. Data from seven consortium sites was included for this FDA nod, among them Emory University, Thomas Jefferson University and the University of California, San Francisco (UCSF).

The company said this clearance is one of the broadest academic collaboration efforts yet applied to developing an FDA-cleared AI algorithm.

Bunkerhill MAC is available in Carebricks, the company’s AI platform for clinical reasoning and action. Carebricks applies AI-powered reasoning—including LLMs and FDA-cleared algorithms—across patient data to customize workflows that automate the 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.”

In March, the company formed a strategic partnership with Cleerly to expand access to their technologies for coronary artery disease detection and risk assessment.