Echo IQ is trading 7.89% down at A$0.53 after the FDA determined on September 9, 2026, that EchoSolv HF was not substantially equivalent to an existing device under the 510(k) pathway.

  • The decision prevents commercial clearance under the current application and delayed the company’s key near-term revenue catalyst.
  • Management is evaluating resubmission and other regulatory options.
  • More than 53 million shares changed hands, versus a one-month average below 2.9 million.