Sydney, November 24, 2025 — Leads & Copy — AI and Medical Technology Company Echo IQ Limited (ASX: EIQ) has successfully completed clinical validation for its EchoSolv HF heart failure clinical decision support software, paving the way for FDA 510(k) submission.
EchoSolv HF validation met the primary endpoint, delivering performance exceeding company expectations in detecting heart failure on an independent dataset.
The study, undertaken across 17,000 individual patient echocardiograms from the Mayo Clinic Platform, highlighted a sensitivity of 99.5%, accurately identifying true positives, and a specificity of 91.0%, detecting true negatives.
The company is now finalizing its FDA 510(k) submission, with lodgement expected in the coming weeks. Following potential FDA clearance, Echo IQ plans to leverage its existing footprint in the U.S. market to drive uptake of EchoSolv HF.
According to Echo IQ, FDA clearance of EchoSolv HF would unlock a major market opportunity in the U.S., where only 50% of heart failure cases are accurately diagnosed. Heart failure is the leading cause of rehospitalization and accounts for 17% of U.S. healthcare expenditure. The total addressable market in the U.S. is estimated at US$60 billion, with approximately 1 in 4 Americans expected to develop heart failure in their lifetime.
Echo IQ will host a webinar at 11:00 a.m. AEDT on Wednesday, November 26, 2025, where CEO Dustin Haines will provide an overview of this development. Nick Lubbers, U.S. Head of Commercial, will also present an update to investors on the company’s progress in the U.S. market. A Q&A session will follow the briefing.
Those wishing to attend the webinar must register in advance via this link: https://us02web.zoom.us/webinar/register/WN_PlLK4Ch4Say6Ahv_cDukqw#/registration
Mr. Dustin Haines, Chief Executive Officer, said that the independent confirmation of the model’s accuracy and reliability through the Mayo Clinic Platform’s Validate program have exceeded internal expectations and provides strong objective evidence supporting the clinical utility of EchoSolv HF in real-world settings.
With the final clinical requirement now complete, the focus shifts to lodging the formal FDA submission in the coming weeks.
With potential FDA clearance, clinicians across the U.S. will be able to use EchoSolv HF as a clinical decision support software to improve the early and accurate detection of heart failure.
Investor Enquiries:
Andrew Grover, Executive Chair
Andrew.grover@echoiq.ai / investor@echoiq.ai
Henry Jordan, Six Degrees Investor Relations
Henry.jordan@sdir.com.au / +61 (0) 431 271 538
Source: Echo IQ Limited
