HeartSciences Inc Stock Price, News & Analysis

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.

HeartSciences (Nasdaq: HSCS) announced the commercial launch of MyoVista Insights version 1.1 on December 11, 2025, a cloud-native ECG reporting and management platform designed to host AI ECG algorithm models from multiple partners.

Version 1.1 emphasizes usability, expanded interoperability across ECG devices and file formats, enhanced waveform tools, streamlined study organization, and workflow efficiency aimed at improving clinical interpretation and reducing operational costs. The company reported early adopter validation and ongoing commercial discussions with leading healthcare institutions since the platform's May 2025 launch.

HeartSciences (NASDAQ: HSCS) reported its Q1 fiscal 2026 results and business updates, highlighting significant progress in its AI-powered ECG technology development. The company successfully launched MyoVista Insights, a cloud-native software platform designed to modernize ECG management systems and serve as an AI-ECG algorithm marketplace.

Key developments include receiving FDA Breakthrough Device designation for their aortic stenosis ECG algorithm and expanding their patent portfolio to 44 granted patents worldwide. The company plans to submit their MyoVista wavECG device for FDA 510(k) clearance this calendar year, with separate submissions for device and software algorithm to streamline review.

Financially, HeartSciences reported no meaningful revenue for Q1 2026, with $2.8 million in cash and $3.1 million in shareholders' equity as of July 31, 2025. Post-quarter, they raised an additional $0.8 million through a Reg A+ offering and converted $0.7 million of debt to equity.

HeartSciences (Nasdaq: HSCS), an AI-powered medical technology company focused on early heart disease detection through ECG/EKG transformation, has announced two upcoming virtual events in August 2025.

The company will host an Investor Webinar on August 20, 2025, at 2:00 PM ET to discuss its mission, market opportunity, and recent progress. Additionally, HeartSciences will present at the Emerging Growth Conference 85 on August 20, 2025, at 3:10 PM ET, offering a business update and interactive Q&A session with investors.

HeartSciences (NASDAQ: HSCS) reported its fiscal 2025 results and business updates, highlighting significant progress in AI-powered ECG technology. The company's flagship MyoVista Insights™ cloud-native software platform launched in May 2025, designed to modernize ECG management systems and serve as a marketplace for AI-ECG algorithms.

Key developments include: CMS approval for AI-ECG algorithm reimbursement at $128 per test, FDA Breakthrough Device designation for their aortic stenosis algorithm, and expansion to 44 granted patents worldwide. The company is preparing for FDA 510(k) submission of its MyoVista wavECG™ device and targets FDA submission of its first cloud-based algorithm for detecting reduced ejection fraction in early 2026.

Financially, HeartSciences reported $1.1 million in cash as of April 30, 2025, and subsequently raised $3.1 million through a Reg A+ offering and converted $0.9 million of debt to equity.

HeartSciences (HSCS) has received FDA Breakthrough Device designation for its AI-powered ECG algorithm designed to detect aortic stenosis. The algorithm, accessible through MyoVista Insights cloud platform, can identify moderate-to-severe aortic stenosis up to 24 months before confirmatory echocardiography. Developed using convolutional neural network deep learning and trained on 120,000+ ECG records, the technology integrates directly with hospital EHR systems without requiring additional hardware. The solution aims to address the critical need for early detection of aortic stenosis, a serious heart valve disease that often progresses silently and can lead to life-threatening outcomes if left untreated. The algorithm offers real-time and retrospective analysis capabilities using existing ECG data and promises expanded access to early diagnosis, particularly in underserved areas.

HeartSciences (NASDAQ: HSCS) has been granted a significant US patent for ECG-based heart function assessment technology. The patent specifically covers the estimation of echocardiography parameters using ECG data, crucial for early heart disease detection. This addition strengthens HeartSciences' intellectual property portfolio, which now comprises 44 total patents - 10 US patents and 34 international patents across major markets including China, Brazil, Canada, India, South Korea, Mexico, and European countries. The company's AI-powered technology aims to transform traditional ECG/EKG capabilities for improved heart disease detection. CEO Andrew Simpson emphasized this patent's importance in establishing HeartSciences as a key player in the AI-ECG field and highlighted its contribution to the company's IP value.

HeartSciences (NASDAQ: HSCS) has secured its first commercial customer, Westcliffe Health Innovations in the UK, for its MyoVista Insights™ platform. This cloud-native ECG management system is designed to be the first vendor- and device-agnostic platform capable of running AI-ECG algorithm models from multiple partners. The implementation will serve as a key reference site within the UK market, particularly for the National Health Service (NHS).

Westcliffe Health Innovations, led by Dr. Matthew Fay, provides cardiology services to the NHS in the Bradford and Leeds region. The partnership aims to enhance clinical decision-making and improve healthcare IT efficiency by streamlining ECG workflows and reducing operational costs. This milestone follows the recent launch of MyoVista Insights and its early adopter program earlier this month.

HeartSciences (Nasdaq: HSCS) announced that CEO Andrew Simpson will present at the Emerging Growth Conference 82 on Wednesday, May 21, 2025 at 10:15 AM EDT. The virtual presentation will include a live Q&A session, providing investors insight into the company's AI-ECG platform and mission.

HeartSciences specializes in AI-powered medical technology focused on transforming ECGs/EKGs for earlier heart disease detection. The presentation will highlight their AI-ECG platform, designed to enhance standard ECG diagnostic capabilities at the point of care. Simpson will also discuss a current Regulation A investment opportunity available to qualified investors.