HeartSciences Submits MyoVista wavECG Device for FDA 510(k) Review

Reuters2025-12-15

HeartSciences Submits MyoVista wavECG Device for FDA 510(k) Review

HeartSciences Inc. has submitted its MyoVista® wavECG™ device to the U.S. Food and Drug Administration (FDA) for 510(k) premarket clearance. The device is designed to offer conventional ECG functionality and serve as a platform for AI-ECG algorithms. The FDA submission marks a significant regulatory milestone for the company as it continues its commercialization efforts. The company has chosen to submit the device and its associated AI-ECG software algorithm separately to simplify the regulatory process and accelerate device clearance. No grant or funding involving HeartSciences Inc. is mentioned.

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 GlobeNewswire (Ref. ID: GNW9601967-en) on December 15, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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