🔴 Echo IQ is trading 11.4% down today after FDA blocked 510(k) clearance for EchoSolv HF

Echo IQ is trading 11.4% down at A$0.51 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 blocks clearance under the current application and delays commercialisation.
• The company is reviewing regulatory issues and possible pathways forward and says it has not abandoned the application.
• Shares have continued falling after the September 9 resumption; the decline is company-specific rather than broad-market driven.