HeartSciences Announces FDA 510(k) Submission for MyoVista® wavECG™ Device
Southlake, TX, Dec. 15, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company advancing the use of ECG/EKGs through the integration of artificial intelligence (“AI”), today announced it has submitted its MyoVista® wavECG™ device to the U.S. Food and Drug Administration (“FDA”) for 510(k) premarket clearance.
The MyoVista wavECG device is designed to provide conventional ECG functionality while serving as a platform capable of hosting AI-ECG algorithm(s). Following the recent publication of updated American Society of Echocardiography (“ASE”) guidelines for the assessment of Left Ventricular Diastolic Dysfunction (“LVDD”), including revised age-based thresholds for cardiac relaxation (e’), the Company elected to separate the FDA submissions for the MyoVista wavECG device and its impaired cardiac relaxation AI-ECG software algorithm. This approach allows the Company to complete additional development and validation work required to update the AI-ECG algorithm to align with the new clinical standards, while advancing the regulatory review of the device independently. Separating the submissions is intended to simplify the regulatory pathway and accelerate clearance of the device. The strategy also preserves flexibility for future deployment of the AI-ECG algorithm across both the MyoVista wavECG device and the Company’s MyoVista® Insights HIT software platform
“The FDA submission of the MyoVista wavECG device represents an important regulatory milestone as we advance our commercialization strategy,” said Andrew Simpson, CEO of HeartSciences. “In parallel, we continue to make meaningful progress with MyoVista InsightsTM, our ECG reporting and management platform, and are engaged in commercial discussions with several healthcare institutions. We expect to announce initial customer deployments as these discussions progress.”
About HeartSciences
HeartSciences is a healthcare information technology (“HIT”) company advancing the use of ECG/EKGs through the integration of artificial intelligence (“AI”). The Company’s MyoVista Insights platform is a device-agnostic, next-generation ECG management system designed to improve clinical efficiency and decision-making. Its MyoVista wavECG device is designed to deliver conventional ECG functionality while supporting on-device AI-enabled solutions.
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Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company's future financial and operating performance. All statements, other than statements of historical facts, included herein are "forward-looking statements" including, among other things, statements about HeartSciences' beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences' Annual Report on Form 10-K for the fiscal year ended April 30, 2025, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 24, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2025 filed with the SEC on September 11, 2025 and in HeartSciences' other filings with the SEC at . Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
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