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EchoIQ Advances US Push With Strong Heart Failure AI Validation and FDA Filing

Story Highlights
  • EchoIQ secured strong clinical validation for its EchoSolv HF AI platform and submitted a 510(k) application to the US FDA after a large Mayo Clinic study showed 99.5% sensitivity and 91.0% specificity in heart failure detection.
  • The company is targeting a US$60 billion US heart failure market as it advances EchoSolv AS uptake, deepens US partnerships, and bolsters industry credibility through the appointment of leading cardiologists to its team.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
EchoIQ Advances US Push With Strong Heart Failure AI Validation and FDA Filing

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EchoIQ Limited ( (AU:EIQ) ) just unveiled an update.

EchoIQ Limited reported major progress in commercialising its AI-powered heart failure diagnostic platform in the US during the December 2025 quarter, highlighted by the clinical validation of EchoSolv HF through the Mayo Clinic Platform’s Validate program. The study, involving around 17,000 independent echocardiograms, met its primary endpoint and exceeded performance expectations, delivering 99.5% sensitivity and 91.0% specificity in detecting heart failure, and the company has now formally submitted a 510(k) premarket notification to the US Food & Drug Administration, with clearance anticipated in the coming months. EchoIQ positions this as a gateway to a US$60 billion US heart failure market, where only about half of cases are accurately diagnosed and heart failure remains the leading cause of rehospitalisation and a major cost driver for the healthcare system, while EchoSolv AS adoption continues to advance through beta testing, system integrations and partner discussions, supported by the appointment of prominent US cardiologists Dr Philippe Genereux and Dr Asif Ali to strengthen the company’s industry presence.

The most recent analyst rating on (AU:EIQ) stock is a Hold with a A$0.40 price target. To see the full list of analyst forecasts on EchoIQ Limited stock, see the AU:EIQ Stock Forecast page.

More about EchoIQ Limited

EchoIQ Limited is an Australian-listed healthcare technology company focused on applying artificial intelligence to echocardiography to improve the diagnosis and management of heart conditions. Its key products include EchoSolv HF, an AI-driven tool for detecting heart failure, and EchoSolv AS, which is being adopted and integrated across the US market, targeting a large and growing cardiovascular disease burden in US healthcare.

Average Trading Volume: 1,467,065

Technical Sentiment Signal: Buy

Current Market Cap: A$247.1M

For an in-depth examination of EIQ stock, go to TipRanks’ Overview page.

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