Echo IQ Confirms Market Clearance Application for Heart Failure Detection Software Submitted To FDA

MT Newswires Live01-23

Echo IQ (ASX:EIQ) confirmed the completion and formal submission of its market clearance application for its heart failure clinical decision support software, EchoSolv HF, on Dec. 15, 2025, via the US Food and Drug Administration's (FDA) 510(k) premarket notification pathway, according to a Friday Australian bourse filing.

It completed clinical validation for its heart failure clinical decision support software, EchoSolv HF, in collaboration with the Mayo Clinic Platform.

The study was designed to evaluate the EchoSolv HF model's ability to detect heart failure on an independent data set of around 17,000 individual echocardiogram studies. The study results show that EchoSolv HF identified heart failure with 99.5% sensitivity and ruled out non-heart-failure patients with 91% specificity.

The total retrospective echocardiograms analyzed by its EchoSolv AS software for the identification of severe aortic stenosis throughout Australia and New Zealand in 2025 were over 55,000. It plans to apply for Therapeutic Goods Administration approvals during the year to further support commercial opportunities.

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