Meditech company Echo IQ (ASX: EIQ) has expanded an agreement with US-based Mayo Foundation for Medical Education and Research to re-sell and distribute its EchoSolv HF heart failure clinical decision support solution.
The revised agreement – which will commence once EchoSolv HF has received clearance from the US Food and Drug Administration (FDA) – will see the product offered through the Mayo Clinic Platform (MCP) Solutions Studio program to the Mayo Clinic health system network and more than 80 external partner hospitals.
Solutions Studio aims to accelerate the development, validation, and deployment of digital health solutions and integrate them into healthcare workflows, alleviating the high costs and complexities that digital health companies face in the commercialisation process and streamlining the adoption of new solutions in hospitals.
The expanded agreement includes an automatic renewal for three years following the initial three-year term.
FDA Market Clearance
A recent study of EchoSolv HF conducted through the MCP validation program demonstrated a sensitivity of 99.5% in identifying patients with heart failure and a specificity of 91.1% in correctly identifying patients without heart failure.
Following the study, Echo IQ lodged a market clearance application with the FDA and is currently progressing through the regulatory review process.
Clearance will allow the company to deploy EchoSolv HF via the MCP, providing potential access to a high-volume clinical network and established distribution pathway.
It represents a key step in Echo IQ’s strategy of converting clinical validation into revenue-generating installations, while supporting broader adoption across hospital networks and platform participants.
Heart failure represents a substantial and growing burden on the US healthcare system, with approximately 6.7 million Americans diagnosed with the condition and a further 2 million undiagnosed.
Significant Market Opportunity
Echo IQ chief executive officer Dustin Haines said FDA clearance had the potential to unlock a significant market opportunity for the company.
“Reaching a more equitable arrangement with one of the most respected hospital systems in the US as we move closer to FDA clearance and commercial deployment leaves us well positioned for the months ahead,” he said.
“This [...] revised agreement provides a scalable pathway to market through the MCP and may give us access to Mayo’s hospital network and a broader ecosystem of healthcare providers seeking validated artificial intelligence solutions.”
The company remains focused on preparing for a rapid commercial rollout, expanding its network of US healthcare partners, and positioning EchoSolv technology as a standard decision support tool within cardiac imaging workflows.
More than 16 million echocardiograms (ECGs) are performed in the US each year, with around half containing heart failure-relevant findings.
