Echo IQ Accelerates US Expansion with FDA Clearance and Mayo Clinic Partnership

FDA Clearance Opens US Market Doors

Echo IQ Limited (ASX:EIQ) has achieved a significant regulatory milestone with the US Food and Drug Administration granting 510(k) clearance for its EchoSolv AS technology. This clearance authorises the marketing and use of EchoSolv AS as a decision support tool for detecting severe Aortic Stenosis (AS), a critical advancement that underpins the company’s US commercialisation strategy.

The FDA’s recognition of EchoSolv AS’s AI-driven diagnostic capabilities not only validates the technology’s medical equivalence but also paves the way for broader adoption across US healthcare providers.

Strategic Collaborations Amplify Reach

Building on regulatory success, Echo IQ secured a collaboration agreement with the prestigious Mayo Clinic Platform to advance validation studies for EchoSolv HF, targeting heart failure detection. This study, set to commence imminently, is a critical step toward FDA clearance anticipated in the second half of 2025.

In addition, the Mayo Clinic Platform’s network of 30 hospitals may license EchoSolv HF, leveraging proprietary integration software to enhance diagnostic workflows. This partnership signals strong institutional endorsement and potential for rapid clinical uptake.

Echo IQ also inked strategic integration agreements with ScImage and MedAxiom, expanding EchoSolv AS deployment to 36 hospitals and cardiology practices. These partnerships leverage ScImage’s cloud-native image management platform and MedAxiom’s cardiovascular network, significantly broadening Echo IQ’s footprint in the US cardiology market.

Leadership and Operational Momentum

Echo IQ strengthened its leadership with the appointment of Dustin Haines as US-based CEO, bringing 25 years of healthcare executive experience, including senior roles at Gilead Sciences. Complementing this, Sam Dribin joined as Chief Technology Officer, tasked with accelerating product integration and AI model refinement.

Operationally, EchoSolv AS is now actively used at six sites, including the flagship Beth Israel Deaconess Medical Center, a Harvard Medical School affiliate performing 30,000 echocardiograms annually. The company anticipates integration at an additional 60 sites in the coming two quarters, underscoring robust pipeline momentum.

Advancing Reimbursement and Market Access

Recognising reimbursement as a critical commercial lever, Echo IQ has filed for a Category III CPT code and is scheduled to present to the Centers for Medicare & Medicaid Services (CMS) to secure this designation. Achieving a dedicated CPT code would facilitate insurance reimbursement, a key catalyst for widespread adoption in the US healthcare system.

Additionally, Echo IQ’s listing on the OTCQB Venture Market in the US aims to enhance investor access and liquidity, supporting ongoing commercialisation efforts.

Global Expansion and Innovation Pipeline

Beyond the US, Echo IQ commenced a fully funded pilot trial in Australia and New Zealand with a leading global structural heart innovation company, focusing on quality assurance and patient recall. This trial will provide valuable data on early detection and health economic benefits.

The company also expanded its intellectual property portfolio with multiple patent filings across major jurisdictions, including the US and Europe, reinforcing its competitive moat.

Echo IQ’s engagement with Curtin University to support cardiovascular monitoring in Indigenous Australian communities highlights a commitment to socially impactful innovation.