HeartSciences recesives FDA BDD for Aortic Stenosis ECG algorithm

HeartSciences (HSCS) announced that the U.S. Food and Drug Administration has granted Breakthrough Device designationless than BDD, for its Aortic Stenosis ECG algorithm. The algorithm would offer a novel, AI-driven ECG solution capable of detecting moderate-to-severe aortic stenosis. Once cleared by the FDA, the algorithm will be accessible through HeartSciences’ MyoVista Insights cloud-based platform which would directly integrate with hospital electronic health record systems, requiring no additional hardware or testing. This technology provides several key clinical advantages: Detection in asymptomatic or under-evaluated patients who may not yet show signs of AS; Real-time or retrospective analysis using existing ECG data already captured during routine care; Expanded access to early diagnosis, especially in underserved areas lacking specialized cardiac imaging or providers.