HeartSciences Announces FDA 510(k) Submission for MyoVista® wavECG™ Device
HeartSciences Inc. (HSCS)
Company Research
Source: GlobeNewswire
Southlake, TX, Dec. 15, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (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 additi
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HSCS
News
- Heart Test Laboratories reports Q2 results [Seeking Alpha]Seeking Alpha
- HeartSciences Reports Fiscal Second Quarter 2026 Financial Results and Provides Business UpdateGlobeNewswire
- HeartSciences Announces Major Upgrade to User Features of MyoVista Insights Platform with Commercial Launch Version 1.1 [Yahoo! Finance]Yahoo! Finance
- HeartSciences Announces Major Upgrade to User Features of MyoVista Insights Platform with Commercial Launch Version 1.1GlobeNewswire
- HeartSciences (NASDAQ:HSCS) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
HSCS
Analyst Actions
- 10/1/25 - Ascendiant Capital
HSCS
Sec Filings
- 12/16/25 - Form 8-K
- 12/15/25 - Form 8-K
- 12/15/25 - Form 10-Q
- HSCS's page on the SEC website