Echo IQ (ASX:EIQ) began work to address the issues cited by the US Food and Drug Administration (FDA) in issuing its "not substantially equivalent" determination for an application for the firm's EchoSolv HF device, according to a Thursday Australian bourse filing.

The firm believes there is a clear path forward to obtaining FDA clearance for the device, which could be achieved over the coming quarters, per the filing. It considers the matters cited to be limited to aspects of statistical analysis supporting the clinical validation after a review of the regulator's feedback, and it did not identify concerns relating to the underlying technology or core functionality of the device.

It identified potential pathways to progress the device towards FDA clearance, including an administrative appeal of the determination, seeking review through the FDA Ombudsman, or submitting a new 510(k) application.