Highlights

  • Echo IQ has filed a request for supervisory review of the FDA's decision on EchoSolv HF.
  • The FDA has accepted the appeal, and its ombudsman has been informed.
  • A meeting with the FDA is expected within the next 30 days.
  • The company expects greater clarity on the regulatory pathway after the meeting.

Echo IQ Limited (ASX:EIQ) has provided an update on the US Food and Drug Administration (FDA) 510(k) process for its EchoSolv HF product. The company has filed an administrative appeal against the FDA's determination that EchoSolv HF is "Not Substantially Equivalent."

Appeal Lodged and Accepted

Echo IQ has filed a request for supervisory review, a form of administrative appeal, of the FDA's decision. The FDA has accepted the appeal, and the agency's ombudsman has been informed.

This update follows the company's earlier announcements on the EchoSolv HF 510(k) application, dated 8 and 17 September 2026.

What Happens Next

A meeting with the FDA about the appeal is expected within the next 30 days. Echo IQ said it expects to have greater clarity on the regulatory pathway for EchoSolv HF after that meeting.

The company has said it will provide further updates to the market as developments occur.

About Echo IQ and the 510(k) Process

Echo IQ is a Sydney-based company that uses AI-driven technology and proprietary software to support decision-making in cardiology. EchoSolv HF is designed to assist in the area of heart failure.

The FDA's 510(k) pathway requires a company to show that its device is substantially equivalent to a device already legally on the market. A "Not Substantially Equivalent" finding means the FDA was not satisfied on this point, and a supervisory review allows the company to ask for that decision to be reconsidered.

Key Takeaways

  • Echo IQ is appealing the FDA's decision on EchoSolv HF.
  • The FDA has accepted the request for supervisory review.
  • A meeting with the FDA is expected within 30 days.
  • The outcome should give clearer direction on the product's US regulatory pathway.