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

HeartSciences Inc. announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to a MyoVista Insights AI-ECG algorithm focused on earlier detection of aortic stenosis from the standard 12-lead ECG. Breakthrough Device Designation is granted to technologies that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.