HeartSciences Inc., an AI-powered medical technology company, announced that it has received FDA Breakthrough Device Designation for its MyoVista Insights AI-ECG algorithm designed to detect Aortic Stenosis. This significant regulatory milestone aims to leverage deep learning to enhance the early detection of this serious heart valve disease. Developed at the Icahn School of Medicine at Mount Sinai, the algorithm offers a seamless integration with hospital electronic health record systems, allowing for early intervention and improved patient outcomes. This breakthrough marks a pivotal step in transforming the approach toward diagnosing and treating Aortic Stenosis, particularly in underserved areas.
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