Echo IQ is trading at A$0.52 (-9.65%) after the FDA issued a Not Substantially Equivalent determination for EchoSolv HF’s initial 510(k) application on September 9, 2026.
- Selling pressure continues following the determination.
- The decision blocks clearance under the current pathway and delays commercialisation, creating a clear company-specific catalyst.
- Trading remains volatile after shares fell sharply when trading resumed following a regulatory-update halt.