🔴 Echo IQ is trading 50% down today after FDA finds EchoSolv HF not substantially equivalent

Echo IQ is trading 50% down at $0.64 after the FDA determined on September 9, 2026, that its EchoSolv HF heart-failure software was not substantially equivalent to an existing device under the 510(k) pathway.

• The decision prevents clearance for commercial use at this stage.
• The company says the 510(k) pathway remains open and is reviewing regulatory options.
• Its FDA-cleared EchoSolv AS platform remains unaffected.