Is this A for Gift Shareholders of Echo IQ Limited - EchoSolv HF Validated at Mayo Clinic Platform – Lining Up for FDA 510(k) Submission
- Noel Ong
- 4 days ago
- 7 min read
Announcement
Exceptional Results from Validation Study for EchoSolv HF 24 November 2025 (click here to view the announcement)
Echo IQ Limited (ASX: EIQ) is pushing its cardiology decision-support platform into the heart failure space, with its EchoSolv HF algorithm now validated through the Mayo Clinic Platform’s independent “Validate” program in the United States.
The Company, based in Sydney with operations anchored out of Western Australia, has completed what it describes as the final clinical requirement ahead of a planned FDA 510(k) submission for EchoSolv HF – a heart failure decision-support solution trained and tested on large-scale echocardiography datasets.
In practical terms, this announcement sits at the intersection of clinical AI, US hospital workflows, and a very large, underserved heart failure market. Echo IQ is positioning EchoSolv HF as a tool that can slot into existing cardiology pathways and help clinicians detect heart failure earlier and more reliably, particularly in a US system where rehospitalisation and misdiagnosis remain material issues.
The Business of the Echo IQ: Focus – Projects
Echo IQ is an AI and medical technology company focused on improving decision-making in cardiology through proprietary, software-based tools. Its core activities and projects, as reflected in this announcement, can be summarised as follows:
Core focus: AI-driven decision support software for cardiology, built around echocardiogram interpretation.
Key product in this release: EchoSolv HF, a heart failure clinical decision support tool intended to support clinicians in identifying patients with heart failure more accurately and earlier.
Partnership setting: Validation undertaken with Mayo Clinic Platform’s Validate program, leveraging independent US clinical data (~17,000 echocardiograms) to test model performance.
Regulatory pathway: EchoSolv HF is being prepared for FDA 510(k) clearance, which would allow the solution to be marketed and used as a clinical decision support tool in the US.
Geographic footprint: Head office presence in Australia (Claremont, WA, and Sydney) with a growing commercial footprint in the United States, including a dedicated US Head of Commercial.
Highlights – EchoSolv HF Validated on 17,000 Mayo Clinic Echocardiograms
Final clinical requirement completed:
Echo IQ has successfully completed a clinical validation study of EchoSolv HF under Mayo Clinic Platform’s Validate program – described as the final clinical requirement prior to FDA 510(k) submission.
Model performance exceeded internal expectations:
Sensitivity: 99.5% – effectively identifying true positives (patients with heart failure).
Specificity: 91.0% – accurately identifying true negatives (patients without heart failure).
Independent, large-scale dataset:
The validation used an independent dataset of approximately 17,000 individual patient echocardiograms, which provides scale and diversity in testing EchoSolv HF’s real-world performance.
Regulatory inflection point approaching:
FDA 510(k) submission is being finalised, with lodgement expected in the coming weeks, according to the Company.
FDA clearance would formally enable US marketing and clinical use of EchoSolv HF as decision-support software in heart failure detection.
Large unmet need in the US heart failure market:
Only ~50% of heart failure cases are accurately diagnosed in current practice.
Heart failure is the leading cause of rehospitalisation in the US and accounts for around 17% of US healthcare expenditure.
The total addressable market for heart failure is cited as US$60 billion.
It is estimated that 1 in 4 Americans will develop heart failure in their lifetime.
Commercial preparation and investor engagement:
Echo IQ intends to leverage its existing US footprint to drive EchoSolv HF uptake, subject to regulatory clearance.
A webinar is scheduled for Wednesday, 26 November 2025 at 11:00am AEDT, featuring CEO Dustin Haines and US Head of Commercial Nick Lubbers, to discuss the validation results and US strategy.
Leadership Commentary
Chief Executive Officer, Mr Dustin Haines, commented:
“Completion of this clinical validation study represents a major milestone in the commercialisation of EchoSolv HF. The independent confirmation of our 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, particularly compared to existing diagnostic tools being utilised across the US. This clinical validation sets Echo IQ on a path to deliver category leading evidence for supporting clinicians in diagnosing heart failure accurately, earlier and more confidently.”
With this final clinical requirement now complete, our focus shifts to lodging the formal FDA submission in the coming weeks. Gaining clearance will enable clinicians across the US to use EchoSolv HF as a powerful decision support software to improve the early and accurate detection of heart failure – a condition that remains significantly under-diagnosed and under-treated. We look forward to advancing this next phase and to working closely with healthcare partners as we prepare for a full commercial rollout.”
About the Project – EchoSolv HF Clinical Validation with Mayo Clinic Platform
The project outlined in the announcement is a clinical validation exercise for EchoSolv HF – Echo IQ’s heart failure decision support tool – carried out under Mayo Clinic Platform’s Validate program.
The key characteristics are:
Objective:
To evaluate the ability of the EchoSolv HF model to detect heart failure on an independent dataset of ~17,000 echocardiogram studies from the Mayo Clinic Platform.
Study design and endpoint:
The primary endpoint was to confirm that EchoSolv HF can accurately identify patients with and without heart failure.
The model achieved 99.5% sensitivity and 91.0% specificity, meeting and exceeding the primary endpoint.
Role of Mayo Clinic Platform Validate:
The Validate program is described as an in-market AI evaluation program that generates an independent and objective report on:
Accuracy
Efficacy
Susceptibility to bias
for AI-based decision software such as EchoSolv HF.
Regulatory significance:
Completion of this study is explicitly stated as the final clinical requirement prior to submitting a formal FDA 510(k) application for EchoSolv HF.
Near-term Milestones to Watch
From this announcement, the near-term milestones appear to be:
FDA 510(k) lodgement:
Finalise documentation and lodge the 510(k) submission in the coming weeks.
FDA review and clearance decision:
Progress through the FDA review process, where timing and outcome remain subject to regulatory assessment and are not guaranteed.
Commercial rollout planning in the US:
Prepare clinical adoption strategies, leveraging existing US footprint and the newly-appointed US Head of Commercial.
Stakeholder engagement and education:
Deliver the 26 November 2025 investor webinar, update investors on validation outcomes and US commercial plans, and continue outreach to hospitals and insurers.
Samso Concluding Comments - Understanding the Investment Memo
IF we look at this announcement and look at the details, t Echo IQ has now delivered a piece of independent clinical evidence that supports the EchoSolv HF story. The validation through the Mayo Clinic Platform is a third-party dataset confirming that the tool performs at the level required for the next regulatory step. That matters because clinical decision-support software must live or die by evidence, not ambition.
From an investment lens, this update appear to de-risks the clinical validation leg of the thesis. The sensitivity and specificity numbers are strong, and they appear to hold up across a large, diverse dataset. That gives Echo IQ a firmer foundation as it moves towards the FDA 510(k) process. However, investors should remember that regulatory clearance is still a hurdle, and the Company is right to emphasise that timing and outcomes remain outside its control.
What is important is to see the market being receptive to the news (Figure 1) in the form or a rising share price. I have always like this story and for those who have missed the Coffee with Samso with Dustin Haines check it out here: An AI Solution to a Cardiovascular Problem | Echo IQ Limited (ASX: EIQ).
Figure 1: The share price chart for EIQ as of 25th November 2025. (source: commsec)
The commercialisation narrative is now entering a more demanding phase. The US heart failure market is large and structurally complex. Hospitals are cautious adopters, and AI-based tools must demonstrate not only accuracy, but workflow fit, economic justification, and operational ease-of-use. Echo IQ is signalling that it has a commercial plan in place — a US head of commercial, early engagement, and a growing footprint — but meaningful traction will depend on converting clinical merit into practical adoption.
In short, this announcement strengthens the technical and regulatory credibility of EchoSolv HF, but the investment case still hinges on Echo IQ proving that it can navigate the realities of US healthcare procurement. The evidence is building, but the next phase requires disciplined execution, clear communication, and a strong focus on early commercial wins that validate the broader opportunity.
The Samso Way – Seek the Research
As always, investors should read the full Echo IQ ASX release, examine the underlying clinical references on heart failure, and consult independent advice before making any investment decisions.
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