HSCS

Southlake, Texas, March 16, 2026 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company focused on advancing electrocardiography (“ECG” or “EKG”) through the integration of artificial intelligence (“AI”), today reported financial results for its fiscal third quarter ended January 31, 2026 (“FQ3 2026”) and provided a business update. Third Quarter and Recent Highlights During the third quarter and subsequent period, the Company continued advancing the commercialization of its MyoVista Insights™ healthcare IT platform and submitted its MyoVista® wavECG™ device to the U.S. Food and Drug Administration (“FDA”) for 510(k) premarket clearance. MyoVista Insights™ Healthcare IT Software Platform Regulatory classification. MyoVista Insights is classified as a Medical Device Data System (“MDDS”), which carries significantly lower regulatory requirements than medical devices and is exempt from FDA 510(k) clearance. As a result, organizational costs and time to commercial rollout are expected to be substantially lower and faster than those associated with regulated medical devices. Platform advancement. Since its early-adopter launch in 2025, the Company has implemented phased upgrades to MyoVista Insights. On March 13, 2026, HeartSciences released a significant version upgrade ahead of the American College of Cardiology (“ACC”) Annual Scientific Session, where the Company will exhibit and publicly introduce the platform to the broader cardiology and healthcare IT community. The upgrade includes mobile phone viewing, reporting enhancements, and significant interoperability improvements designed to support deployment across large health systems. Commercial traction. During 2026 the Company’s objectives include establishing key reference sites and generating initial revenues. HeartSciences has already made commercial progress with reference installations and endorsement from a hospital network. Early feedback has been compelling, and the Company is currently in discussions with multiple health systems regarding deployment. Management expects to announce several key customer wins during 2026. AI-ECG marketplace opportunity. In addition to generating per-test SaaS revenues as a secure cloud-based ECG data management system, MyoVista Insights is purpose-built to enable the integrati...

Southlake, TX, Dec. 15, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company focused on advancing electrocardiography (“ECG” or “EKG”) through the integration of artificial intelligence (“AI”), today reported financial results for its fiscal second quarter ended October 31, 2025 (“FQ2 2026”) and provided a business update. Second Quarter and Recent Highlights During the second quarter and subsequent period, the Company made significant progress in the commercialization and advancement of its MyoVista Insights™ healthcare IT platform and submitted its MyoVista® wavECG™ device to the U.S. Food and Drug Administration (“FDA”) for 510(k) premarket clearance. MyoVista Insights™ Healthcare IT Software MyoVista Insights is classified as a Medical Device Data System (“MDDS”), which carries significantly lower regulatory requirements and is exempt from 510(k) clearance. As a result, the organizational costs and speed of commercial rollout are expected to be substantially lower and faster than those associated with regulated medical devices. Since its launch in May 2025, and following the recent release of Version 1.1, MyoVista Insights has received strong validation from early adopters. The Company is currently engaged in commercial discussions with several healthcare institutions for deployment and expects to announce multiple key customer wins in the near term. In addition to generating per-test, SaaS-based revenues as an ECG reporting and management system, MyoVista Insights is designed as a platform capable of hosting third-party AI-ECG algorithms through an AI-ECG marketplace. The Company is in discussions with several partners to host FDA-cleared algorithms. Management believes this platform uniquely positions HeartSciences to capture a multibillion-dollar market opportunity while significantly reducing the cost and time required for algorithm development and regulatory clearance. The Company plans to host an investor call early in the new year, during which it will demonstrate the MyoVista Insights software and provide additional details regarding its commercialization strategy and market opportunity. MyoVista® wavECG™ Device The Company has submitted its MyoVista® wavECG™ device to the FDA for 510(k) premarket clearance. HeartSciences elected to separate the FDA subm...

Southlake, TX, Sept. 11, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), an artificial intelligence (“AI”)-powered medical technology company transforming ECGs/EKGs to enable earlier detection of heart disease, today announced its financial results for the first quarter of fiscal 2026 ended July 31, 2025 (“FQ1 2026”) and provided a business update highlighting continued progress. First Quarter and Recent Highlights HeartSciences has made substantial progress during FQ1 2026 which saw the Company achieve an FDA Breakthrough Device Designation and successfully launched MyoVista Insights. MyoVista Insights™ Software Platform HeartSciences successfully developed and launched MyoVista Insights, a cloud-native software platform designed to modernize legacy ECG management systems and serve as a marketplace for AI-ECG algorithms. We have invested millions of dollars in the past 18 months to create a platform designed for use with existing ECG devices and to integrate into hospital EHR systems and existing clinical workflows while eliminating the need for a healthcare provider to purchase new ECG devices. MyoVista Insights has been designed to provide an AI-ECG marketplace to enable clinical institutions to access both HeartSciences’ and third-party AI-ECG algorithms from millions of ECG devices already in use globally. Importantly, the platform can be implemented onto existing ECG hardware infrastructure with no required capital expenditures, making adoption both seamless and cost-efficient. CPT reimbursement codes are now in place for AI-ECG which would cover algorithms provided by MyoVista Insights, using any compatible ECG device. These codes have been approved by CMS (Medicare) for billing are additive to conventional ECG test reimbursement. This enhanced reimbursement framework is expected to support AI-ECG adoption across the healthcare system by benefiting key stakeholders. Hospitals and institutions could increase revenue. Insurers could benefit from earlier interventions and save significant costs. associated with acute care Physicians could make better, earlier diagnosis. Most importantly, patients experience improved care outcomes. The platform began a phased rollout in May 2025, launching at early adopter reference sites. Phase 2 is anticipated to be launched alongside the Company’s first cloud-based...

Southlake, TX, July 24, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), an artificial intelligence (“AI”)-powered medical technology company transforming ECGs/EKGs to enable earlier detection of heart disease, today announced its financial results for the fiscal year ended April 30, 2025, and provided a business update highlighting significant strategic progress. Fiscal 2025 and Business Highlights HeartSciences made substantial advancements during fiscal year 2025, marking a pivotal shift in its strategy to enhance the clinical value of ECGs through AI and cloud-based technologies that can be deployed across diverse healthcare settings—from major hospital systems to mobile nurse-led testing services. MyoVista Insights™ Software Platform HeartSciences successfully developed and launched its MyoVista Insights, a cloud-native software platform designed to modernize legacy ECG management systems and serve as a marketplace for AI-ECG algorithms. The platform is being designed to be used with existing ECG devices and integrate into hospital EHR systems thus seamlessly integrating itself into clinical workflows while eliminating the need to buy new devices. MyoVista Insights enables clinical institutions to access both HeartSciences’ and third-party AI-ECG algorithms from the millions of ECG devices already in use globally. The platform began a phased rollout in May 2025, launching at early adopter reference sites. Phase 2 will be launched alongside the Company’s first cloud-based algorithm for detecting reduced ejection fraction, which is targeted for FDA submission in the first half of calendar year 2026 with potential clearance later that year. Ultimately, the Company aims for MyoVista Insights to become the first cloud-native ECG management software stack, replacing outdated, on-premise solutions in a multibillion-dollar market. MyoVista® wavECG™ Device HeartSciences is nearing FDA 510(k) submission for its MyoVista wavECG device, with most final testing now complete. In July 2025, the American Society of Echocardiography released updated guidelines for evaluating Left Ventricular Diastolic Dysfunction (“LVDD”), placing increased emphasis on the echocardiographic measure for impaired cardiac relaxation (e’) and now requiring age-based threshold adjustments. The device’s embedded impaired cardiac relaxation...

Southlake, TX, March 13, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), an artificial intelligence (“AI”)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today reported financial results for the third quarter fiscal 2025 ended January 31, 2025 and provided a business update. Third Fiscal Quarter 2025 Highlights: During the third quarter of fiscal year 2025 (“Q3 FY2025”) and to date in 2025, HeartSciences has seen material progress towards FDA submissions of our products and there have been significant positive developments in the AI-ECG field. A summary of the current status and key business highlights for Q3 FY2025 include: AI-ECG presents a generational opportunity to modernize the ECG industry, one of the most ubiquitous medical tests in the world. ECGs are generally decades-old devices, outdated technology and rely on legacy reporting and managements systems. By enhancing both hardware and software, HeartSciences enables earlier and more accurate detection of heart disease, bridging a critical diagnostic gap in frontline healthcare. HeartSciences is the only company building next-gen ECG device hardware, device agnostic cloud-native software and AI-ECG algorithms. Our versatility will enable us to deliver AI-ECG solutions across a variety of healthcare settings, ranging from large hospital systems to simple nurse-led mobile testing services. The final pre-submission meeting for the MyoVista® wavECGTM device took place with the FDA in February 2025 and we expect to finalize the FDA study clinical validation in a few weeks. Assuming this is successful, we anticipate submiting the device for FDA clearance within the first half of calendar 2025. The Company is in active discussions for MyoVista® InsightsTM to be implemented in test sites during 2025, which followed on-scheduled completion of Phase 1, in December 2024. MyoVista Insights is a cloud-native, cybersecure modern technology stack operating on a device agnostic basis for the millions of ECGs in place today. It is intended to radically upgrade ECG reporting and does not require regulatory clearance (as it is reporting based). Phase 2, which is subject to regulatory clearance, will add AI-ECG reporting. The Company has developed the system to provide both proprietary an...