HeartSciences: FDA Grants Breakthrough Device Designation For Aortic Stenosis ECG Algorithm
FDA Breakthrough Device Designation: HeartSciences has received FDA Breakthrough Device designation for its AI-driven ECG algorithm that detects moderate-to-severe aortic stenosis, developed at the Icahn School of Medicine by Dr. Akhil Valid.
Market Response: Following the announcement, shares of HeartSciences rose by 6% in pre-market trading on Wednesday.
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HeartSciences Partners with Cibolo Health for ECG Management
- Partnership Agreement: HeartSciences has partnered with Cibolo Rural Health Networks, selecting MyoVista Insights™ as the endorsed ECG management platform for 123 independent hospitals, enhancing healthcare quality and efficiency.
- Technology Integration: With MyoVista Insights, Cibolo Health's hospitals will modernize ECG workflows, enabling physicians to interpret ECGs more quickly and efficiently, thereby improving clinical decision-making processes.
- Cloud Platform Advantages: MyoVista Insights offers secure cloud-based ECG data management, supporting various devices and file formats, ensuring regulatory-compliant AI-ECG algorithms can be integrated into routine clinical practice, enhancing accessibility to healthcare services.
- Strategic Implications: This collaboration aligns with Cibolo Health's mission to optimize care delivery while also driving HeartSciences' market expansion within high-value networks, strengthening its competitive position in the healthcare information technology sector.
HeartSciences Submits MyoVista Device to FDA, Advancing AI ECG Technology
- Product Advancement: HeartSciences submitted its MyoVista® wavECG™ device to the FDA for 510(k) clearance at the end of its fiscal second quarter on October 31, 2025, marking a significant regulatory milestone that is expected to accelerate the product's market entry.
- Software Platform Validation: Since its launch in May 2025, the MyoVista Insights™ platform has received strong validation from early adopters and is currently engaged in commercial discussions with several healthcare institutions, with multiple key customer wins expected to be announced soon, further driving revenue growth.
- Market Opportunity: As a Medical Device Data System, MyoVista Insights carries significantly lower regulatory requirements, which is anticipated to substantially reduce the costs and speed of commercial rollout, enabling the company to quickly tap into a multibillion-dollar market opportunity.
- Financial Position: As of October 31, 2025, HeartSciences reported approximately $2.0 million in cash and cash equivalents and $4.2 million in shareholders' equity, and while no meaningful revenue was generated in FQ2 2026, the company is actively advancing its commercialization strategy.
HeartSciences Submits MyoVista Device for FDA 510(k) Clearance
- Regulatory Milestone: HeartSciences has submitted its MyoVista wavECG device for FDA 510(k) clearance, aiming to expedite the regulatory review process, which is expected to enhance the company's competitiveness in the healthcare IT sector.
- Technological Innovation: The device not only provides conventional ECG functionality but also supports AI-ECG algorithms, aligning with the latest ASE guidelines for LVDD assessment, which is anticipated to improve clinical decision-making and patient care quality.
- Flexible Development Strategy: The company opted to separate the FDA submissions for the device and the AI-ECG software algorithm to simplify the regulatory pathway and accelerate device clearance while preserving flexibility for future AI-ECG deployments, enhancing market adaptability.
- Market Expansion Potential: CEO Andrew Simpson noted that progress with the MyoVista Insights platform is occurring in parallel with the device submission, with initial customer deployments expected to be announced soon as commercial discussions with several healthcare institutions advance, further driving revenue growth.
Ascendiant Capital Reaffirms Buy Rating on HeartSciences, Reduces Price Target to $9
Real-time Intelligence: Benzinga Pro offers the fastest news alerts to help traders stay informed and make winning trades in the stock market.
Exclusive Community: Joining Benzinga Pro connects users with over 10,000 serious traders and provides access to exclusive stories and insights from Benzinga reporters.
HeartSciences Shares Business Update and Announces Financial Results for First Quarter of Fiscal 2026
Company Overview: HeartSciences Inc. is an AI-powered medical technology company focused on enhancing ECGs/EKGs for earlier heart disease detection, recently achieving FDA Breakthrough Device Designation and launching the MyoVista Insights software platform.
MyoVista Insights Launch: The MyoVista Insights platform modernizes ECG management systems, allowing integration with existing devices and hospital workflows without additional capital expenditures, while also introducing CPT reimbursement codes for AI-ECG algorithms.
Financial Performance: For the first quarter of fiscal 2026, HeartSciences reported no significant revenue, with approximately $2.8 million in cash and $3.1 million in shareholders' equity, but has since raised additional funds to strengthen its balance sheet.
Future Plans: The company aims to submit its MyoVista wavECG device for FDA approval and expand its intellectual property portfolio, while positioning itself to achieve regulatory clearances and initial revenues in 2026.
Join the Live Stream of Day 1 at the Emerging Growth Conference 85 on August 20; Registration Now Open
Emerging Growth Conference Announcement: The 85th Emerging Growth Conference is scheduled for August 20 & 21, 2025, focusing on companies with strong management and growth potential across various sectors.
Day 1 Schedule Highlights: Keynote speakers include CEOs from companies such as Immuron Limited, Nutriband, Inc., and Journey Medical Corporation, presenting their innovative products and strategies.
Day 2 Schedule Highlights: Presentations will feature executives from Eshallgo, Inc., Grove Collaborative Holdings, Inc., and U.S. Energy Corporation, among others, discussing their business developments.
Engagement and Participation: Attendees can register for the conference, submit questions to presenting companies, and access replays via the EmergingGrowth.com platform.
HeartSciences Partners with Cibolo Health for ECG Management
- Partnership Agreement: HeartSciences has partnered with Cibolo Rural Health Networks, selecting MyoVista Insights™ as the endorsed ECG management platform for 123 independent hospitals, enhancing healthcare quality and efficiency.
- Technology Integration: With MyoVista Insights, Cibolo Health's hospitals will modernize ECG workflows, enabling physicians to interpret ECGs more quickly and efficiently, thereby improving clinical decision-making processes.
- Cloud Platform Advantages: MyoVista Insights offers secure cloud-based ECG data management, supporting various devices and file formats, ensuring regulatory-compliant AI-ECG algorithms can be integrated into routine clinical practice, enhancing accessibility to healthcare services.
- Strategic Implications: This collaboration aligns with Cibolo Health's mission to optimize care delivery while also driving HeartSciences' market expansion within high-value networks, strengthening its competitive position in the healthcare information technology sector.
HeartSciences Submits MyoVista Device to FDA, Advancing AI ECG Technology
- Product Advancement: HeartSciences submitted its MyoVista® wavECG™ device to the FDA for 510(k) clearance at the end of its fiscal second quarter on October 31, 2025, marking a significant regulatory milestone that is expected to accelerate the product's market entry.
- Software Platform Validation: Since its launch in May 2025, the MyoVista Insights™ platform has received strong validation from early adopters and is currently engaged in commercial discussions with several healthcare institutions, with multiple key customer wins expected to be announced soon, further driving revenue growth.
- Market Opportunity: As a Medical Device Data System, MyoVista Insights carries significantly lower regulatory requirements, which is anticipated to substantially reduce the costs and speed of commercial rollout, enabling the company to quickly tap into a multibillion-dollar market opportunity.
- Financial Position: As of October 31, 2025, HeartSciences reported approximately $2.0 million in cash and cash equivalents and $4.2 million in shareholders' equity, and while no meaningful revenue was generated in FQ2 2026, the company is actively advancing its commercialization strategy.
HeartSciences Submits MyoVista Device for FDA 510(k) Clearance
- Regulatory Milestone: HeartSciences has submitted its MyoVista wavECG device for FDA 510(k) clearance, aiming to expedite the regulatory review process, which is expected to enhance the company's competitiveness in the healthcare IT sector.
- Technological Innovation: The device not only provides conventional ECG functionality but also supports AI-ECG algorithms, aligning with the latest ASE guidelines for LVDD assessment, which is anticipated to improve clinical decision-making and patient care quality.
- Flexible Development Strategy: The company opted to separate the FDA submissions for the device and the AI-ECG software algorithm to simplify the regulatory pathway and accelerate device clearance while preserving flexibility for future AI-ECG deployments, enhancing market adaptability.
- Market Expansion Potential: CEO Andrew Simpson noted that progress with the MyoVista Insights platform is occurring in parallel with the device submission, with initial customer deployments expected to be announced soon as commercial discussions with several healthcare institutions advance, further driving revenue growth.
Ascendiant Capital Reaffirms Buy Rating on HeartSciences, Reduces Price Target to $9
Real-time Intelligence: Benzinga Pro offers the fastest news alerts to help traders stay informed and make winning trades in the stock market.
Exclusive Community: Joining Benzinga Pro connects users with over 10,000 serious traders and provides access to exclusive stories and insights from Benzinga reporters.
HeartSciences Shares Business Update and Announces Financial Results for First Quarter of Fiscal 2026
Company Overview: HeartSciences Inc. is an AI-powered medical technology company focused on enhancing ECGs/EKGs for earlier heart disease detection, recently achieving FDA Breakthrough Device Designation and launching the MyoVista Insights software platform.
MyoVista Insights Launch: The MyoVista Insights platform modernizes ECG management systems, allowing integration with existing devices and hospital workflows without additional capital expenditures, while also introducing CPT reimbursement codes for AI-ECG algorithms.
Financial Performance: For the first quarter of fiscal 2026, HeartSciences reported no significant revenue, with approximately $2.8 million in cash and $3.1 million in shareholders' equity, but has since raised additional funds to strengthen its balance sheet.
Future Plans: The company aims to submit its MyoVista wavECG device for FDA approval and expand its intellectual property portfolio, while positioning itself to achieve regulatory clearances and initial revenues in 2026.
Join the Live Stream of Day 1 at the Emerging Growth Conference 85 on August 20; Registration Now Open
Emerging Growth Conference Announcement: The 85th Emerging Growth Conference is scheduled for August 20 & 21, 2025, focusing on companies with strong management and growth potential across various sectors.
Day 1 Schedule Highlights: Keynote speakers include CEOs from companies such as Immuron Limited, Nutriband, Inc., and Journey Medical Corporation, presenting their innovative products and strategies.
Day 2 Schedule Highlights: Presentations will feature executives from Eshallgo, Inc., Grove Collaborative Holdings, Inc., and U.S. Energy Corporation, among others, discussing their business developments.
Engagement and Participation: Attendees can register for the conference, submit questions to presenting companies, and access replays via the EmergingGrowth.com platform.
