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HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis
Globenewswire· 2025-06-04 13:00
Core Insights - HeartSciences Inc. has received FDA Breakthrough Device designation for its AI-driven ECG algorithm designed to detect Aortic Stenosis, a serious heart valve disease [1][5] Company Overview - HeartSciences is focused on advancing ECG technology using AI to enhance early detection of heart diseases, aiming to improve healthcare outcomes [5] - The company has developed one of the largest libraries of AI-ECG algorithms and plans to offer these solutions through a cloud-based platform that integrates with existing hospital EHR systems [5] Technology and Innovation - The AI-ECG algorithm can detect moderate-to-severe Aortic Stenosis up to 24 months before confirmatory echocardiography, utilizing advanced convolutional neural network techniques trained on over 120,000 ECG records [3][4] - The algorithm is designed for seamless integration with hospital systems, requiring no additional hardware or testing, thus enhancing clinical utility [3] Clinical Impact - Early detection of Aortic Stenosis through this algorithm allows for timely interventions, potentially improving patient outcomes and reducing the risk of irreversible myocardial damage [2][4] - The technology aims to expand access to early diagnosis, particularly in underserved areas lacking specialized cardiac imaging [7]
Foundational US Patent Granted for ECG Assessment of Heart Function, Further Expands HeartSciences’ Patent Portfolio and IP Value
Globenewswire· 2025-06-03 13:00
Core Insights - HeartSciences Inc. has been granted a foundational patent by the USPTO for estimating echocardiography parameters using an ECG, enhancing its intellectual property portfolio [1] - The company has a total of 44 granted patents, including 10 US patents and 34 international patents across key markets [2] - The CEO of HeartSciences emphasized the strength of their AI-ECG algorithm patent portfolio, positioning the company as a significant player in the AI-ECG field [3] Company Overview - HeartSciences is focused on applying AI technology to ECGs to improve their clinical utility, aiming to enhance cardiac screening, especially in frontline clinical settings [5] - The company possesses one of the largest libraries of AI-ECG algorithms and plans to offer these algorithms through a cloud-based solution and a low-cost ECG hardware platform [5] - The MyoVista® wavECG™, the company's first product candidate for FDA clearance, is designed to provide diagnostic information related to cardiac dysfunction alongside conventional ECG data [5]
HeartSciences Signs First MyoVista Insights™ Platform Customer, Marking Major Commercial Milestone
GlobeNewswire News Room· 2025-05-29 13:00
Core Insights - HeartSciences Inc. has signed its first commercial customer, Westcliffe Health Innovations, for its MyoVista Insights™ platform, marking a significant milestone in its commercial journey [1][7] - The MyoVista Insights platform aims to enhance ECG management and improve clinical decision-making through AI technology, positioning itself as a vendor- and device-agnostic solution [4][8] Company Overview - HeartSciences is focused on applying AI technology to ECGs to improve their clinical utility, particularly in frontline healthcare settings [8] - The company has developed a large library of AI-ECG algorithms and aims to provide these through a cloud-based solution alongside low-cost ECG hardware [8] Product Details - MyoVista Insights is a cloud-native ECG management system designed to streamline workflows and reduce operational costs for healthcare providers [4] - The platform is intended to facilitate easy access to ECGs and expert interpretation, particularly in areas with socio-economic challenges [6] Partnership Significance - The partnership with Westcliffe Health Innovations is expected to establish it as a key reference site for HeartSciences in the UK market [3] - Dr. Matthew Fay, a prominent figure in UK cardiology, emphasizes the importance of easy access to ECGs in addressing cardiovascular disease in the community [5][6]
HeartSciences’ CEO Andrew Simpson to Present at Emerging Growth Conference 82 on Wednesday, May 21, 2025
Globenewswire· 2025-05-20 13:00
Core Insights - HeartSciences Inc. is focused on transforming ECGs/EKGs through AI technology to enhance early detection of heart disease [1][4] - The company will present at the Emerging Growth Conference 82, providing insights into its mission and market opportunities [2] - HeartSciences is offering a Regulation A investment opportunity for qualified investors, allowing access to investment terms typically unavailable in public markets [2] Company Overview - HeartSciences utilizes innovative AI-based technology to improve the clinical utility of ECGs, aiming to enhance cardiac screening, especially in frontline clinical settings [4] - The company possesses one of the largest libraries of AI-ECG algorithms and plans to offer these algorithms through a cloud-based solution and a low-cost ECG hardware platform [4] - The MyoVista® wavECG™, the company's first product candidate for FDA clearance, provides diagnostic information related to cardiac dysfunction alongside conventional ECG data [4]
HeartSciences to Host Investor Webinar and Q&A on Wednesday May 14, 2025 - Featuring CEO Andrew Simpson
Globenewswire· 2025-05-08 13:00
Core Viewpoint - HeartSciences Inc. is leveraging AI technology to enhance ECG diagnostics, aiming to improve early detection of heart disease and save lives [1][3]. Group 1: Company Overview - HeartSciences is focused on transforming ECGs/EKGs through AI to enhance their clinical utility, particularly in frontline clinical settings [3]. - The company possesses one of the largest libraries of AI-ECG algorithms and plans to offer these algorithms via a cloud-based solution and a low-cost ECG hardware platform [3]. - The first product candidate, MyoVista® wavECG™, is a resting 12-lead ECG that provides diagnostic information related to cardiac dysfunction, traditionally available only through cardiac imaging [3]. Group 2: Market Opportunity - The AI-ECG platform is designed to significantly improve the diagnostic capabilities of standard ECGs, enabling faster and earlier detection of heart disease at the point of care [2]. - The upcoming investor webinar on May 14, 2025, will provide insights into HeartSciences' mission and market opportunities, along with a discussion on the current Regulation A investment opportunity [2]. Group 3: Investment Information - HeartSciences is offering securities under Tier II of Regulation A, providing qualified investors access to investment opportunities typically unavailable in public markets [2][5].
HeartSciences Adds Prominent Key Advisors to its Scientific Advisory Board
Globenewswire· 2025-05-07 13:00
Core Viewpoint - HeartSciences Inc. has appointed three distinguished experts to its Scientific Advisory Board, enhancing its commitment to advancing AI-driven ECG technology for early heart disease detection [1][2]. Group 1: Appointments and Expertise - Dr. Girish Nadkarni, Dr. Joshua Lampert, and Dr. Akhil Vaid have been appointed to the Scientific Advisory Board, bringing extensive expertise in cardiology, AI, and data-driven healthcare [1][2]. - Dr. Nadkarni is a physician-scientist with significant contributions to AI and precision medicine, holding over 375 peer-reviewed publications and an h-index of 90, and has secured approximately $40 million in research funding [3][4]. - Dr. Lampert specializes in cardiac electrophysiology and machine learning, focusing on improving patient care through novel diagnostic tools and has received multiple awards for his contributions to patient care [5][6][8]. - Dr. Vaid is involved in applying machine learning in cardiology, with a focus on developing AI models for cardiac dysfunction detection and ensuring practical implementation of AI solutions in clinical settings [9][10][11]. Group 2: Company Overview and Objectives - HeartSciences is dedicated to enhancing the clinical utility of ECGs through innovative AI technology, aiming to improve cardiac screening, particularly in frontline clinical settings [12]. - The company possesses one of the largest libraries of AI-ECG algorithms and plans to offer these solutions via a cloud-based platform alongside a low-cost ECG hardware option [12]. - HeartSciences' first product candidate, the MyoVista® wavECG™, aims to provide diagnostic information related to cardiac dysfunction, traditionally available only through cardiac imaging, while also delivering conventional ECG data [12].
HeartSciences Announces Launch of MyoVista Insights™ Platform and Related Early Adopter Program
Globenewswire· 2025-05-01 13:00
Core Viewpoint - HeartSciences Inc. has launched the MyoVista Insights platform, an AI-powered ECG management system aimed at improving heart disease detection and healthcare efficiency [1][2]. Group 1: Product Overview - MyoVista Insights is a cloud-native ECG Management System designed to enhance clinical decision-making and healthcare IT efficiency, integrating AI-ECG algorithms in future releases [2][3]. - The platform is vendor-agnostic, allowing it to run AI-ECG algorithm models from multiple partners, featuring a standardized ECG reporting protocol for consistent interpretation [3]. - It includes patient-centric display protocols for tracking disease progression over time, ensuring intuitive workflows for both clinicians and healthcare IT professionals [4]. Group 2: User Experience and Feedback - Clinicians have praised MyoVista Insights for its user-friendly design and enhanced ECG usability, which improves workflow efficiency and clinical value [4][5]. - Feedback from healthcare professionals has been overwhelmingly positive, indicating a strong interest in the early adopter program [5]. Group 3: Technical and Financial Aspects - MyoVista Insights is built on a secure AWS technology stack, meeting high data security and compliance standards, and operates on a pay-as-you-go model to reduce costs associated with legacy systems [4]. - The platform aims to significantly lower the total cost of ownership for healthcare providers while enhancing cybersecurity [4]. Group 4: Company Background - HeartSciences focuses on applying innovative AI technology to ECGs to improve their clinical utility, particularly in frontline clinical settings [6]. - The company possesses one of the largest libraries of AI-ECG algorithms and aims to provide these solutions on a cloud-based platform alongside a low-cost ECG hardware option [6].
Heart Test Laboratories(HSCS) - 2025 Q3 - Quarterly Results
2025-03-13 20:16
[Form 8-K Filing for HeartSciences Inc.](index=1&type=section&id=Form%208-K%20Filing%20for%20HeartSciences%20Inc.) [Company Information and Securities](index=1&type=section&id=Company%20Information%20and%20Securities) HeartSciences Inc., an emerging growth company, lists Common Stock (HSCS) and Warrants (HSCSW) on Nasdaq - The registrant is HeartSciences Inc., located in Southlake, Texas, and is classified as an emerging growth company[2](index=2&type=chunk)[6](index=6&type=chunk) Securities Registered Pursuant to Section 12(b) of the Act | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :--- | :--- | :--- | | Common Stock | HSCS | The Nasdaq Stock Market LLC | | Warrants | HSCSW | The Nasdaq Stock Market LLC | [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) HeartSciences Inc. issued a press release on March 13, 2025, detailing Q1 2025 financial and operational results - The company issued a press release on March 13, 2025, providing financial and operating results for the quarter ended January 31, 2025[7](index=7&type=chunk) - The information provided in the press release (Exhibit 99.1) is not deemed "filed" under Section 18 of the Exchange Act, which limits its legal liability in certain contexts[8](index=8&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists Form 8-K exhibits, notably Exhibit 99.1, the press release detailing financial results Exhibits Filed | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release dated March 13, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
HeartSciences Provides Business Update and Reports Third Quarter Fiscal 2025 Financial Results
Globenewswire· 2025-03-13 20:15
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 t ...
Heart Test Laboratories(HSCS) - 2025 Q3 - Quarterly Report
2025-03-13 20:03
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended January 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-41422 HEARTSCIENCES INC. (Exact Name of Registrant as Specified in its Charter) Securities registered pursuant to Section 12(b) of the Act: | | Trading | | | --- ...