Dec. 15, 2025 — HeartSciences Inc., a healthcare information technology company advancing the use of ECG/EKGs through the integration of artificial intelligence, 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 guidelines for the assessment of Left Ventricular Diastolic Dysfunction, 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 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. This also preserves flexibility for future deployment of the AI-ECG algorithm across both the MyoVista wavECG device and the 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 Insights, 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.”
For more information, please visit: www.heartsciences.com.
June 16, 2026 
