HeartSciences Inc. filed a 510(k) pre‑market clearance application with the U.S. Food and Drug Administration for its MyoVista® wavECG™ device on December 15 2025. The filing marks the first regulatory step toward commercial launch of the 12‑lead ECG platform that embeds on‑device artificial‑intelligence algorithms for early detection of left‑ventricular diastolic dysfunction.
The MyoVista® wavECG™ platform separates the hardware from its AI‑ECG software, allowing the company to pursue independent regulatory pathways for each component. This strategy enables continued validation of the impaired cardiac relaxation algorithm against updated American Society of Echocardiography guidelines while advancing the device’s clearance independently, a move that could shorten the time to market and reduce regulatory risk.
HeartSciences currently has no meaningful revenue and holds approximately $1.1 million in cash and cash equivalents as of April 30 2025. The company’s subscription‑based revenue model is contingent on FDA clearance, and the filing is a critical milestone toward unlocking that model. The company’s cash burn remains high, and it has relied on prior fundraising rounds to sustain operations, underscoring the importance of regulatory approval for future funding and profitability.
The AI‑ECG market is projected to reach roughly $25 billion, while the broader AI‑healthcare market is valued at $379 billion. In 2025, Centers for Medicare & Medicaid Services approved reimbursement for AI‑ECG algorithms at $128 per test under the Hospital Outpatient Prospective Payment System, creating a clear revenue pathway once the device is cleared. The combination of a sizable market, favorable reimbursement, and a subscription model positions HeartSciences to capture a meaningful share of the growing AI‑cardiology segment.
HeartSciences competes with established cardiology equipment makers such as GE Healthcare, Philips, and Siemens Healthineers, which bundle hardware and software. By offering a device‑agnostic platform, HeartSciences aims to differentiate itself and gain a competitive edge. The company also holds FDA “Breakthrough Device” designation for its aortic stenosis ECG algorithm, further validating its technology and accelerating potential market entry.
CEO Andrew Simpson said the FDA submission “represents an important regulatory milestone as we advance our commercialization strategy.” He added that the company is progressing with the MyoVista Insights platform and is in advanced commercial discussions, signaling confidence in the company’s ability to translate regulatory approval into market adoption.
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