Echo IQ Boosts Echocardiogram Processing 153%, FDA Submission Imminent
Echo IQ reports a remarkable 153% increase in echocardiogram processing through its EchoSolv AS platform in the US, with a Mayo Clinic validation study nearing completion ahead of a critical FDA submission. The company is also advancing European market entry and strengthening its advisory team to accelerate global growth.
- 153% growth in US echocardiogram processing from July to September 2025
- Mayo Clinic validation study for EchoSolv HF to complete imminently, enabling FDA submission
- Integration completed with ScImage and beta testing with SARC MedIQ expands US hospital network
- Strategic advisors Dr Phillipe Genereux and Dr Asif Ali appointed to support US market and regulatory efforts
- Advanced negotiations underway for European distribution and CE Mark regulatory approval
Strong US Market Momentum
Echo IQ Limited has reported a significant operational uplift in the third quarter of 2025, with its EchoSolv AS platform processing 153% more echocardiograms in the United States compared to previous months. This surge reflects growing adoption among fully integrated US hospital customers and underscores the platform’s increasing role in cardiac diagnostics.
The company’s CEO, Dustin Haines, highlighted that this growth is foundational to a broader commercial scale-up planned for 2026, with revenue impacts expected to begin flowing through in the final quarter of 2025. Echo IQ is actively advancing conversion strategies with qualified leads, including ongoing demonstrations and beta testing with major hospital groups.
Regulatory Milestone Approaching
A pivotal moment is on the horizon as Echo IQ anticipates the completion of its Mayo Clinic validation study for EchoSolv HF this month. This independent clinical evaluation is critical for the company’s upcoming FDA 510(k) submission, marking the final regulatory hurdle before potential clearance. Given heart failure’s status as a leading cause of rehospitalisation and a US$60 billion market, FDA approval could unlock substantial commercial opportunities.
Expanding US Hospital Network and Strategic Expertise
Echo IQ has completed integration with ScImage, a cloud-based workflow platform with over 1,200 US users, and finalized beta testing with SARC MedIQ, which services more than 300 healthcare facilities. These partnerships are expected to accelerate platform adoption across a broad network of hospitals and clinics.
Further bolstering its US presence, Echo IQ appointed two renowned cardiologists as strategic advisors, Dr Phillipe Genereux, a leading authority on structural heart disease, and Dr Asif Ali, an expert in AI-driven cardiovascular medicine. Their involvement is expected to enhance clinical credibility, support regulatory submissions, and facilitate new integrations within major hospital systems.
European Market Entry and Global Studies
On the international front, Echo IQ is in advanced negotiations with a European distributor to introduce its EchoSolv technology to the EU market. Concurrently, the company is pursuing CE Mark approval, which would broaden its regulatory footprint and commercial reach in Europe, where heart valve disease and heart failure impose significant health and economic burdens.
Complementing these efforts, Echo IQ has initiated a global health economic outcome study in partnership with the National Echo Database Australia. This research aims to quantify the clinical and cost benefits of earlier AI-driven detection of cardiac conditions, potentially strengthening the case for widespread adoption of Echo IQ’s technology.
Overall, Echo IQ’s recent operational achievements, strategic hires, and regulatory progress position it well for accelerated growth in the competitive cardiac diagnostics market.
Bottom Line?
With FDA submission imminent and EU expansion underway, Echo IQ is poised for a transformative phase in global cardiac care innovation.
Questions in the middle?
- When exactly will FDA clearance for EchoSolv HF be granted, and what will be the timeline for commercial rollout?
- How quickly will the new US hospital integrations translate into meaningful revenue growth?
- What impact will the pending European distribution agreement and CE Mark approval have on Echo IQ’s global market share?
