HeartSciences Receives FDA Breakthrough Device Designation for Aortic Stenosis AI-ECG Algorithm

HSCS
September 20, 2025
HeartSciences Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its Aortic Stenosis (AS) ECG algorithm. Aortic Stenosis is a serious and common heart valve disease that often progresses silently, leading to severe outcomes if undetected. This designation recognizes the algorithm's potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. The algorithm offers a novel, AI-driven ECG solution capable of detecting moderate-to-severe aortic stenosis. Once cleared by the FDA, this algorithm will be accessible through HeartSciences' MyoVista Insights cloud-based platform, integrating directly with hospital electronic health record systems without requiring additional hardware. This technology provides key clinical advantages by enabling earlier identification of aortic valve disease. The algorithm was developed using advanced convolutional neural network deep learning techniques and trained on over 120,000 ECG records. Performance evaluations showed its ability to detect aortic stenosis up to 24 months prior to confirmatory echocardiography, with diagnostic accuracy increasing as the disease progressed. CEO Andrew Simpson stated this designation has the potential to transform how this serious disease is detected, leading to earlier referrals and improved patient outcomes. The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.