Echo IQ Nears FDA Submission as US EchoSolv Usage Surges 153%

• Clinical validation study with Mayo Clinic Platform nearing completion
• EchoSolv AS platform usage in US hospitals up 153% in the quarter
• Reseller agreement with SARC MedIQ expands access to 300+ US healthcare facilities
• Two leading cardiologists appointed as strategic advisors to support US growth
• European distribution deal and CE Mark regulatory engagement approaching finalisation

Clinical Validation Accelerates FDA Pathway

Echo IQ Limited has marked a pivotal step in its regulatory journey with the commencement and near completion of a clinical validation study for its EchoSolv HF heart failure decision support software, conducted in partnership with the prestigious Mayo Clinic Platform. This study represents the final independent dataset required before the company can formally submit its 510(k) application to the US Food and Drug Administration (FDA). The Mayo Clinic’s involvement not only lends significant credibility but also signals the technology’s potential to transform heart failure diagnosis through AI-driven insights.

Surging Adoption in the US Market

Alongside regulatory progress, Echo IQ has reported a remarkable 153% increase in the use of its FDA-approved EchoSolv AS platform across key US hospital sites during the quarter. This momentum continued into October with an additional 58% uplift in echocardiogram processing. The company’s reseller agreement with SARC MedIQ, a US-based AI imaging platform provider with access to over 300 healthcare facilities and 1,500 physicians, is poised to further accelerate adoption. Beta testing with SARC MedIQ has been completed, and integration is underway, positioning EchoSolv for broader penetration in the competitive cardiology diagnostics market.

Strategic Partnerships and Expert Guidance

Echo IQ has also strengthened its US presence by onboarding two distinguished cardiologists as strategic advisors – Dr Philippe Genereux, a leading interventional cardiologist and Medical Director at Morristown Medical Center, and Dr Asif Ali, a key opinion leader in cardiovascular imaging and AI innovation. Their expertise is expected to bolster regulatory engagement, clinical validation efforts, and commercial expansion. Additionally, the company completed onboarding with ScImage, a specialist diagnostics workflow platform with a 1,200-strong US user base, further extending EchoSolv’s reach.

International Expansion on the Horizon

Echo IQ is advancing its global footprint with near-final negotiations for a European distribution agreement. This move aims to facilitate CE Mark regulatory approval and entry into the European Union market, where heart failure-related costs exceed €29 billion annually. The company’s strategic focus on both US and international markets reflects a comprehensive approach to scaling its AI-driven cardiology solutions.

Financial Position and Outlook

Financially, Echo IQ reported operating cash outflows of A$2.514 million for the quarter, supported by a strong cash balance of A$15.9 million and no debt. The company’s management remains confident in its ability to fund ongoing operations and commercial initiatives. Looking ahead, the next quarter is expected to deliver the completion of the Mayo Clinic validation study, formal FDA submission for EchoSolv HF, and continued expansion of US and international partnerships, setting the stage for sustained growth into 2026 and beyond.

Bottom Line?

Echo IQ’s clinical validation and commercial traction set the stage for a critical FDA submission and accelerated growth in cardiology AI.

Questions in the middle?

• When exactly will the FDA submission for EchoSolv HF be formally lodged and reviewed?
• How quickly will the SARC MedIQ and ScImage integrations translate into revenue growth?
• What are the prospects and timelines for CE Mark approval and European market entry?