AI-driven medtech company Echo IQ (ASX: EIQ) has taken a major step forward in bringing its heart failure clinical decision support solution, EchoSolv HF, to market. The company has secured a collaboration agreement with the Mayo Clinic Platform, one of the world’s leading medical institutions, to conduct a critical validation study—the final hurdle before FDA submission in H2 2025.
Key Developments
- Positive engagement with FDA: Echo IQ’s pre-submission meeting with the FDA confirmed a clear path to securing regulatory approval for EchoSolv HF.
- Mayo Clinic collaboration: The Mayo Clinic Platform will oversee EchoSolv HF’s validation study and has secured rights to use the AI solution across 30 Mayo Clinic Care Network hospitals for three years.
- Final validation study commencing this quarter: This study will evaluate EchoSolv HF’s ability to detect various types of heart failure. Completion is expected mid-2025, paving the way for FDA submission in H2 2025.
- Breakthrough AI performance: EchoSolv HF has demonstrated 86% standalone detection accuracy, increasing to 97% when combined with clinical evaluation—far outperforming the 46% detection rate of standard clinical practice.
Why This Matters
Heart failure is a US$70 billion market in the United States, with 10 million echocardiograms performed annually for heart failure assessment. Yet, only 50% of cases are accurately diagnosed, leading to high rehospitalisation rates and significant healthcare costs. EchoSolv HF’s AI-driven accuracy could revolutionise heart failure diagnosis, ensuring earlier intervention and better patient outcomes.
CEO Commentary
Echo IQ CEO Dustin Haines said:
“Our meeting with the FDA was highly encouraging and has given us confidence in our path to regulatory clearance. The collaboration with Mayo Clinic Platform further validates EchoSolv HF’s potential impact on heart failure detection. With previous Australian studies showing up to 97% accuracy, we’re eager to commence our validation study and work towards delivering better patient outcomes at scale.”
With regulatory milestones on track and a partnership with one of the most respected medical institutions globally, Echo IQ is positioning itself as a leader in AI-powered cardiovascular diagnostics.
