HeartSciences Announces FDA 510(k) Submission for MyoVista® wavECG™ Device

Rhea-AI Summary

HeartSciences (Nasdaq: HSCS) submitted its MyoVista wavECG device to the U.S. FDA for 510(k) premarket clearance on December 15, 2025. The device provides conventional ECG functionality and is a platform to host AI-ECG algorithms. Following updated ASE guidelines for LV diastolic dysfunction, the company separated the device and its impaired cardiac relaxation AI-ECG algorithm into two FDA submissions to allow additional algorithm development and validation under the new clinical thresholds.

The separate-submission strategy aims to simplify the regulatory pathway, accelerate device clearance, preserve deployment flexibility across the MyoVista device and MyoVista Insights HIT platform, and support pending commercial discussions and expected initial customer deployments.

Positive

• 510(k) submission filed for MyoVista wavECG on Dec 15, 2025
• Device built as a platform to host AI-ECG algorithms
• Submission separation preserves deployment flexibility across platforms
• Company engaged in commercial discussions and expects initial deployments

Negative

• No FDA clearance yet; regulatory approval remains uncertain
• AI-ECG algorithm requires additional development and validation
• Separation may delay combined device+algorithm commercial rollout

Key Figures

Cash balance $2.8 million As of July 31, 2025 (Q1 FY26 update)

Shareholders’ equity $3.1 million As of July 31, 2025 (Q1 FY26 update)

Reg A+ proceeds $0.8 million Capital raised post Q1 FY26 quarter-end

Debt converted $0.7 million Debt-to-equity conversion post Q1 FY26

CMS reimbursement $128 per test Approved rate for AI-ECG algorithm

Granted patents 44 patents Worldwide patent portfolio as of recent updates

Cash balance $1.1 million As of April 30, 2025 (FY 2025 results)

S-8 registered shares 209,857 shares Form S-8 for 2023 Equity Incentive Plan

Market Reality Check

$2.47 Last Close

Volume Volume 18,244 vs 20-day average 36,927 (relative volume 0.49) indicates subdued trading ahead of this news. low

Technical Shares at $2.55 were trading below the 200-day MA of $3.37, and about 60.59% below the 52-week high of $6.47.

Peers on Argus 1 Down

Pre-news, HSCS was down 2.67% with mixed moves among medical device peers: RSLS up 29.8%, BMRA up 1.98%, while PAVM and SSKN were down 4.9% and 3.4%. Momentum scans only flagged LFWD moving down, suggesting stock-specific rather than broad sector drivers.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 11	Platform upgrade launch	Positive	+0.0%	Commercial launch of MyoVista Insights v1.1 with enhanced usability and interoperability.
Sep 11	Earnings & update	Neutral	-10.0%	Q1 FY26 results, MyoVista Insights launch, Breakthrough designation, low revenue and small cash base.
Aug 15	Investor outreach	Neutral	-3.4%	Announcement of investor webinar and Emerging Growth Conference participation for business updates.
Jul 24	Full-year results	Positive	+0.3%	Fiscal 2025 results, CMS reimbursement win, AI-ECG platform launch, and capital raises improving liquidity.

Pattern Detected

Recent news skewed toward positive AI-ECG and platform milestones, with mixed price follow-through and at least one instance where strong product news saw no immediate reaction.

Recent Company History

Over the last six months, HeartSciences has focused on advancing its AI-ECG ecosystem. On Jul 24, 2025, it reported fiscal 2025 results, highlighting the launch of MyoVista Insights and CMS reimbursement at $128 per test, with modest positive price reaction. Subsequent conference and investor outreach on Aug 15, 2025 saw a small decline. The Q1 FY26 update on Sep 11, 2025 detailed platform progress but no meaningful revenue and triggered a 10.03% drop. The Dec 11, 2025 MyoVista Insights v1.1 launch produced no price move, showing that operational progress has not always been rewarded.

Market Pulse Summary

This announcement details FDA 510(k) submission for the MyoVista wavECG device, a key regulatory step that separates hardware clearance from future AI-ECG software approvals. It follows earlier milestones, including CMS reimbursement at $128 per test, launch of the MyoVista Insights platform, and expansion to 44 patents. Investors may monitor progress on validating algorithms under updated ASE LVDD guidelines, initial customer deployments for MyoVista Insights, and future financial updates on revenue traction and cash resources.

Key Terms

510(k) regulatory

"submitted its MyoVista® wavECG™ device to the U.S. Food and Drug Administration (“FDA”) for 510(k) premarket clearance."

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

artificial intelligence technical

"advancing the use of ECG/EKGs through the integration of artificial intelligence (“AI”)"

Artificial intelligence is the ability of computers and machines to perform tasks that typically require human thinking, such as understanding language, recognizing patterns, or making decisions. For investors, it matters because AI can enhance efficiency, uncover new insights, and enable smarter strategies, potentially impacting the value and performance of companies that develop or utilize this technology.

U.S. Food and Drug Administration regulatory

"submitted its MyoVista® wavECG™ device to the U.S. Food and Drug Administration (“FDA”)"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

AI-generated analysis. Not financial advice.

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 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 Insights^TM, 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.

For more information, please visit: https://www.heartsciences.com. X: @HeartSciences.

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 www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Investor Relations:
Integrous Communications
Mark Komonoski, Partner
Phone: 877 255 8483
Email: mkomonoski@integcom.us

Media Contact:
HeartSciences
Gene Gephart
+1 682 244 2578 Ext. 2024
info@heartsciences.com

FAQ

What did HeartSciences (HSCS) announce on December 15, 2025?

HeartSciences announced it submitted the MyoVista wavECG device to the FDA for 510(k) premarket clearance on Dec 15, 2025.

Why did HSCS separate the MyoVista device and AI-ECG algorithm FDA submissions?

The company separated submissions to allow additional algorithm development to align with updated ASE LVDD thresholds and to accelerate device regulatory review.

Does the MyoVista wavECG include AI capabilities now for HSCS (HSCS)?

The device is a platform to host AI-ECG algorithms, but the impaired cardiac relaxation AI algorithm remains a separate submission requiring further validation.

How might the 510(k) submission affect HSCS commercialization timeline?

Separating submissions is intended to simplify the regulatory pathway and may accelerate device clearance, though AI deployment timing depends on further validation.

Will the AI-ECG algorithm be deployable across other HeartSciences platforms (HSCS)?

Yes; the company said the separate approach preserves flexibility to deploy the AI algorithm across the MyoVista device and MyoVista Insights HIT platform.

Has HeartSciences announced any customer deployments for HSCS products?

The company is engaged in commercial discussions and expects to announce initial customer deployments as those discussions progress.