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Echo IQ's EchoSolv HF Device Deemed 'Not Substantially Equivalent' by US FDA

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Echo IQ (ASX:EIQ) failed to secure commercial clearance for its EchoSolv HF device after the US Food and Drug Administration (FDA) found its initial 510(k) application "not substantially equivalent," according to an Australian bourse filing on Tuesday after market hours.

The company is evaluating the US FDA's concerns with regulatory, legal, and statistical advisers and believes a potential pathway to clearance remains, per the filing.

An applicant whose medical device has been deemed not substantially equivalent may resubmit another 510(k) application with new data, request a Class I or II designation, file a reclassification petition, or submit a premarket approval application, according to the FDA's website.

The decision does not affect the FDA-cleared EchoSolv AS platform or its commercialization in the US, the company said.

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