• Successful lodgement of FDA 510(k) submission for EchoSolv HF
• Submission includes results from clinical validation study with Mayo Clinic
• FDA clearance could unlock significant market opportunity in the US

Echo IQ Limited (ASX: EIQ) has announced the formal lodgement of its market clearance application for EchoSolv HF, its heart failure clinical decision support software, with the US Food & Drug Administration (FDA) via the 510(k) premarket notification pathway. The submission incorporates results from a clinical validation study conducted specifically to support the 510(k) application. The study, designed to validate the model's ability to detect heart failure on an independent dataset, showed EchoSolv HF met the primary endpoint with study data demonstrating sensitivity of 99.5% and specificity of 91.0% in the detection of heart failure across a dataset of 17,000 echocardiograms from Mayo Clinic Platform. FDA clearance, if obtained, would unlock a significant addressable market opportunity for EchoSolv HF in the US healthcare sector, where heart failure is the leading cause of hospitalisation and accounts for 17% of US healthcare expenditure nationally.

With the submission process complete, Echo IQ will continue to work with its network of industry partners across both product development and distribution, ahead of an expected FDA decision in the coming months. The ongoing advancement of the company's healthcare technology suite positions it for another momentum-driven year ahead, leveraging its proprietary technology to deliver improved healthcare solutions.