HeartSciences gets FDA Breakthrough Device designation for AI-ECG algorithm detecting aortic stenosis

HeartSciences Inc.

FDA granted Breakthrough Device designation for HeartSciences' Aortic Stenosis AI-ECG algorithm.
Algorithm detects moderate-to-severe aortic stenosis via MyoVista Insights cloud platform integrated with EHR.
Trained on >120,000 ECG records; can detect AS up to 24 months before echocardiography.
No additional hardware required; uses existing ECG data for real-time or retrospective analysis.

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