HeartSciences submits MyoVista wavECG device for FDA 510(k) review

Reuters03-17

HeartSciences submits MyoVista wavECG device for FDA 510(k) review

Heartsciences said it submitted its MyoVista wavECG device to the FDA for 510(k) premarket clearance. The company also said it separated the FDA submissions for the device and its impaired cardiac relaxation AI-ECG algorithm following updated American Society of Echocardiography guidance on left ventricular diastolic dysfunction.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Heartsciences Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001437749-26-008420), on March 16, 2026, and is solely responsible for the information contained therein.

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