Key Highlights

• Echo IQ is progressing regulatory work for its cardiac decision-support technology in the United States.

• FDA preparation, submission, acceptance and clearance represent different stages of the regulatory process.

• Commercial activity provides an operating base, although Revenue remains modest relative to development ambitions.

• Formal regulatory updates and customer adoption will shape the next phase of progress.

Echo IQ (ASX:EIQ) halted its shares on 7 September 2026 and returned the following day with the update small-cap MedTech holders dread. The United States Food and Drug Administration had ruled the company's heart failure algorithm Not Substantially Equivalent, shutting the clearance route Echo IQ had travelled since December.

The determination applies to EchoSolv HF alone. EchoSolv AS, the company's aortic stenosis decision-support tool, was cleared by the FDA in October 2024 and continues to be sold in the United States. The two products are routinely conflated, and that difference is now the most important fact about the company.

The stock changed hands at about $1.28 on 8 September 2026, valuing the company near $948 million.

Cleared, submitted and refused are three different things

EchoSolv AS holds a 510(k) clearance granted in October 2024, permitting its use as a decision-support aid in detecting severe aortic stenosis alongside conventional echocardiography. That clearance is unaffected.

EchoSolv HF followed a different arc. Echo IQ lodged a 510(k) premarket notification for the heart failure product on 15 December 2025, after a validation study run through Mayo Clinic Platform across roughly 17,000 echocardiogram studies reported sensitivity of 99.5 per cent and specificity of 91 per cent.

A Not Substantially Equivalent ruling is not a verdict on that data. It is the FDA saying the device cannot be matched to an existing predicate under the 510(k) framework. The company said it would engage with the agency to clarify the points raised and weigh its regulatory options, adding that it still believes a route through 510(k) remains viable. No De Novo application has been confirmed.

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A commercial base that is real but small

The cleared product is being used. Echo IQ told shareholders it processed more than 10,200 echocardiograms in the June quarter, up 20 per cent sequentially and more than 400 per cent year on year, with a United States hospital pipeline exceeding 70 facilities. EchoSolv AS has been deployed into Mount Sinai Health System, and a reseller agreement with SARC MedIQ opened a network of some 300 facilities on a per-scan fee.

Turning scans into money remains the harder problem. The American Medical Association declined Echo IQ's application for a Category III CPT code in October 2025, and the shares fell sharply on the day. The company has been billing through miscellaneous code 93799 while pursuing an appeal and a proposed class of artificial intelligence reimbursement codes. Reported revenue stays negligible against losses running to tens of millions.

Cash is not the constraint

Echo IQ finished June with $8.7 million, then raised roughly $110 million in an institutional Placement completed in July 2026, alongside a binding heads of agreement with Pro Medicus worth up to $20 million. That deal gives Pro Medicus rights to market Echo IQ's cardiovascular software across its United States customer base. Cash exceeded $105 million in July 2026.

One term now looks awkward. Pro Medicus committed an initial $10 million through secured convertible notes, with a further $10 million contingent on FDA clearance of EchoSolv HF. The refusal pushes that Tranche further away.

The near-term milestones are procedural rather than commercial: the dialogue with the FDA, whatever resubmission or alternative pathway emerges from it, and an investor webinar flagged in the same 8 September lodgement. Any timeline for EchoSolv HF should be treated as unsettled until Echo IQ names its pathway and the agency responds.