FDA Clears CT-Based AI For Detection of Mitral Annular Calcification

The Food and Drug Administration (FDA) has granted 510(k) clearance for Bunkerhill MAC, an emerging artificial intelligence (AI) algorithm for detecting and quantifying mitral annular calcification (MAC) on non-gated chest computed tomography (CT) scans.

While research has demonstrated that MAC is associated with elevated cardiovascular risks and mortality rates, this condition, which involves the buildup of calcium deposits in the mitral valve ring, is often an incidental finding with inconsistent reporting on chest CTs, according to Bunkerhill Health, the developer of Bunkerhill MAC.

The company emphasized that the Bunkerhill MAC software, which is available through the company’s clinical AI platform Carebricks, was developed and tested through research conducted at 25 leading medical centers.

"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, the 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."