Echo IQ (ASX: EIQ): Strong Operational Momentum & Regulatory Milestones. Recent Setback May Be A Discount Opportunity for Investors - Diagnosing Heart Disease.
- Noel Ong
- 9 hours ago
- 8 min read
Announcement
Echo IQ Limited (ASX: EIQ) has delivered a concise update showing rising clinical usage for EchoSolv™ AS, clear progress on EchoSolv™ HF’s FDA pathway, and expanding commercial channels in the US and Europe. The near-term catalysts are anchored in actual hospital integrations, validation work nearing completion, and newly appointed US key opinion leaders guiding adoption.
Chief Executive Officer, Mr Dustin Haines, commented:
“Echo IQ continues to build strong momentum across all key workstreams. Achieving a consistent growth rate of echocardiogram processing with fully integrated EchoSolv AS US customers has underpinned strong momentum to date in the American market and highlights increased usage of our technology ahead of a broader scale up and sales push across a range of qualified leads.”
“At the same time, our FDA submission pathway for EchoSolv HF remains firmly on track, supported by the pending completion of our Mayo Clinic validation study in the coming weeks. This data will form an important foundation for our FDA submission, which will follow in quick succession upon completion of the trial and marks the final regulatory piece prior to FDA clearance in the coming months.”
1.0 Strong Operational Momentum 2 October 2025 - Diagnosing Heart Disease
Usage inflection in the US: Echocardiograms processed on EchoSolv AS at fully integrated US sites increased 153% from July–September 2025. Management frames this as a major milestone ahead of broader conversion activities.
Global throughput: >90,000 echocardiograms analysed to date across trials and business development initiatives, underscoring platform scale.
Regulatory path (HF): Mayo Clinic Platform validation is scheduled to complete this month, with FDA 510(k) submission for EchoSolv HF to follow shortly thereafter—the final step before clearance.
Commercial channels:
◽ ScImage onboarding/integration completed; partner network spans ~1,200 US users.
◽ SARC MedIQ beta complete; reach across ~300 facilities and ~1,500 physicians.
ANZ pilot momentum: 50,000+ retrospective echocardiograms analysed across Australia/New Zealand via a fully-funded pilot with a leading structural heart company.
US KOL bench strength: Appointments of Dr Philippe Genereux (Morristown MC; structural heart authority) and Dr Asif Ali (University of Texas/Houston Cardiology Consultants; digital health/AI advocate) to drive adoption and integrations.
EU expansion: Final-stage negotiations with a specialist distributor and pursuit of CE Mark to broaden the global footprint.
Outcomes & economics: Health-economic study with NEDA underway to quantify mortality, hospitalisation, surgical trends, and system cost impacts from earlier AI-driven detection (AS/HF).
Operational Update — US Adoption & Conversion
Engagement with fully integrated US hospital groups has driven a 153% rise in processed echos (Jul–Sep 2025). Echo IQ is now advancing a conversion strategy across qualified leads, with final demos/beta testing ongoing at large hospital groups and clinics, and expects the usage uplift to begin flowing into revenue in Q4 CY2025 ahead of a broader CY2026 scale-up.
Figure 1: Current sales & integration pipeline (source: EIQ)
Regulatory — EchoSolv HF (FDA 510(k))
The Mayo Clinic Platform validation (via Mayo Validate) is slated to complete this month; data will underpin the 510(k) submission within weeks, marking the final regulatory piece prior to clearance. The addressable HF market is large, with significant US burden and under-utilisation of evidence-based therapies—supporting the commercial rationale for EchoSolv HF.
Commercial Channels — ScImage & SARC MedIQ
ScImage integration is complete, positioning EchoSolv within a ~1,200-user US workflow ecosystem (with added traction via the MedAxiom network). SARC MedIQ beta is complete, enabling access to ~300 facilities/~1,500 physicians and an active sales push across their network.
Advisors — Clinical Influence & Site Access
Dr Philippe Genereux (Structural Heart Program, Morristown Medical Center) and Dr Asif Ali (UT Houston/Houston Cardiology Consultants) join as strategic advisors, supporting US integration opportunities and regulatory submissions. Negotiations for integrations tied to these appointments are advancing within large US hospitals.
ANZ Pilot — Scale & Quality Focus
In Australia/New Zealand, 50,000+ retrospective echos have been analysed under a fully funded medical device pilot with a leading structural heart innovator, focused on quality assurance and patient recall programs that surface at-risk patients for further review.
Europe — Market Entry & CE Mark
Echo IQ is in advanced discussions with a specialist EU distributor and is pursuing CE Mark to enable broader regional commercialisation across AS/HF use cases.
Evidence & Health Economics — NEDA Collaboration
A health economic outcomes study with NEDA is underway to quantify mortality/hospitalisation impacts, intervention trends, and cost/resource utilisation benefits from earlier AI-led detection—evidence that can support adoption decisions by payors and providers.
Next Steps
Mayo validation completion (this month) → FDA 510(k) submission (EchoSolv HF) shortly after.
US integrations via ScImage/SARC networks; ongoing demos/beta and conversion across qualified leads.
EU distributor agreement finalisation and CE Mark engagement.
NEDA health-economic study outcomes to evidence clinical and cost benefits.
2.0 Category III CPT code application update 6 October 2025
US reimbursement update:
The AMA did not grant a Category III CPT code for EchoSolv™ AS (decision filed 3 Oct US time).
According to the company, Echo IQ will consider a reconsideration request within 14 days, continue supporting customers via Miscellaneous Code 93799, and is engaging with the AMA on the proposed Clinically Meaningful Algorithmic Analysis (CMAA) AI code framework, anticipated to roll out in CY2026.
Chief Executive Officer, Mr Dustin Haines, commented:
“This is a frustrating outcome, however, we respect the AMA’s decision and their current stance around AI-based technologies. Despite this decision, we are confident that ongoing engagement with the regulatory body will help ensure that EchoSolv AS remains front of mind, particularly as new frameworks for AI-based technologies, such as the proposed CMAA codes are developed.”
“While more robust reimbursement remains a key factor in our commercialisation journey, the Company is continuing to advance a number of initiatives, including expanding our commercial use with Miscellaneous Code 93799, regulatory engagement with the FDA for EchoSolv HF, expanded US deployments of the EchoSolv platform and partnerships which will strengthen the commercialisation of our technology. These parallel efforts leave Echo IQ well positioned to drive adoption and unlock long term value for shareholders.”
Samso Concluding Comments
The latest news is not the outcome that Echo IQ would prefer. As we all know in this sector, the line between being accepted and not accepted by the FDA can be very fine. It is also pertinent to remember that the decision does not mean that the technology is not valid. There is due process required and the company needs to do what it needs to do. Companies like EchoIQ do not present themselves to the FDA without knowing that their product holds up in concept and in practice.
In regards to the story of Echo AI - Diagnosing Heart Disease, the company is continuing to highlight usage at integrated US sites is rising, the validation work for EchoSolv™ HF has defined endpoints and timing, and channel partners already touch meaningful clinical workflows. That combination—real usage + tight regulatory sequencing + existing distribution—is what typically separates intent from execution.
Disregarding the setback recently, investors should keep their attention on three proof points: (1) sustained throughput growth at fully integrated sites; (2) the completion of the Mayo validation and the timing of the 510(k) submission for HF; and (3) tangible conversion from pilots and demos into paying deployments via ScImage/SARC networks. Each of these is measurable and should show up in the cadence of quarterly updates.
Investors need to remember that the EchoSolv narrative is a proven concept from the company's point of view. So this may be the opportunity for shareholders to get in on the story at a market discount.
Figure 2: The share price chart for EchoIQ Limited as of 14th October 2025. (source: commsec)
As an investor, situations like this highlight a step in the decision-making when it comes to parting with your hard-earned money. Is this a misstep that will be recovered from is it a significant milestone that breaks the story? This is the decision that investors must make, and as I have always said, DYOR.
The ANZ pilot and the NEDA health-economic work matter because adoption in cardiology isn’t won on algorithms alone; it’s won on workflow fit and clinical/economic outcomes. If EchoSolv continues to surface at-risk patients earlier and demonstrates reduced downstream costs, the conversation with providers and payers gets simpler.
As always, none of this is a recommendation. Samso’s view is that the story is building the right way—evidence first, then scale. Track the milestones, read the primary documents, and DYOR. However, if you are chasing a discount, the time may be perfect for that investment strategy.
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