- 01FDA not substantially equivalent for EchoSolv HF.
- 02Engage FDA; pursue 510(k) path.
- 03EchoSolv AS remains FDA-cleared.
- 04Cash >$105m; US growth plan continues.
Echo IQ (ASX: EIQ) is reviewing its regulatory options after the US Food and Drug Administration issued a not substantially equivalent determination for the initial EchoSolv HF 510(k) application, meaning the product has not received clearance for commercial use at this time.
The company has begun a detailed assessment with its US regulatory and legal advisers, study partners, and independent statistical experts, and still believes that a pathway to clearance remains available under the 510(k) route.
Echo IQ plans to engage directly with the FDA to clarify the matters raised and determine the most appropriate and efficient way to progress EchoSolv HF towards US regulatory clearance.
The decision does not affect the FDA-cleared EchoSolv AS platform, while Echo IQ had more than $105 million in cash at bank as of July 2026 to support its continuing commercial and development work.
Regulatory Review Underway
“While we are disappointed in the decision on our initial application and our view differs on certain aspects, the determination provides us with detailed feedback that we can now assess with our US regulatory and legal advisors and, importantly, discuss directly with the FDA,” chief executive officer Dustin Haines said.
“Our immediate priority is to understand the matters raised in full and determine the most efficient pathway forward.”
Echo IQ remains confident in the clinical rationale for EchoSolv HF and continues to see significant unmet clinical need in identifying patients with heart failure.
The company intends to continue the EchoSolv HF regulatory program rather than alter its broader US commercial strategy while the review is underway.
Broader US Strategy Continues
Echo IQ will continue expanding the commercial infrastructure supporting EchoSolv AS in the US, where uptake of the FDA-cleared platform is growing, alongside work on its reimbursement pathway, customer pipeline and strategic relationships.
Those activities are intended to provide an established platform for the future commercialisation of EchoSolv HF if the required regulatory clearance is ultimately obtained.
The company will also continue investing in its broader research and development pipeline, including solutions targeting additional disease states and new clinical modalities designed to extend the EchoSolv platform across cardiovascular care and into other areas of clinical need.
“Echo IQ is approaching this next phase from a position of strength—we have an FDA-cleared product in EchoSolv AS, a growing US presence, important strategic relationships, and a strong balance sheet,” Mr Haines said.
“These foundations remain unchanged and provide us with the resources and infrastructure required to progress the additional work necessary to advance EchoSolv HF towards regulatory clearance.”
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