HeartSciences Inc. reported financial results for its fiscal second quarter ended October 31, 2025, and provided a business update focusing on the advancement of electrocardiography through AI integration.
The company made progress in commercializing the MyoVista Insights™ healthcare IT platform and submitted its MyoVista® wavECG™ device to the FDA for 510(k) premarket clearance.
MyoVista Insights™ Healthcare IT platform received positive validation from early adopters and is expected to capture a significant market opportunity hosting AI-ECG algorithms.
MyoVista Insights Platform
Classified as a Medical Device Data System, expected to have lower regulatory requirements and faster commercial rollout than regulated medical devices.
Commercial Progress
Engaged in commercial discussions with healthcare institutions, expecting key customer wins in the near term for the MyoVista Insights platform.
AI-ECG Marketplace
Platform designed to host third-party AI-ECG algorithms, strategically positioning HeartSciences to reduce time and cost for algorithm development.
MyoVista® wavECG™ Device
Submitted to FDA for 510(k) premarket clearance, representing a milestone in modernizing ECG with artificial intelligence.
Financial Results
Reported minimal revenue for FQ2 2026, with $2.0 million in cash and cash equivalents and $4.2 million in shareholders' equity as of October 31, 2025.
- The MyoVista Insights platform aims to deliver clinical, operational, and data security benefits for healthcare systems, enhancing decision-making efficiency.
- Submission of the MyoVista wavECG device to the FDA represents a regulatory milestone that aligns with the company's strategy to modernize ECG through AI.
HeartSciences is poised for growth with positive validation of its healthcare IT platform and the milestone of submitting its wavECG device for FDA clearance, signaling advancements in ECG technology with AI integration.