Echo IQ has requested a supervisory review after the U.S. Food and Drug Administration (FDA) deemed its EchoSolv HF device “Not Substantially Equivalent” in its initial 510(k) application. The FDA has accepted the administrative appeal, and the agency’s ombudsman has been notified.
The appeal advances the company’s effort to secure U.S. market clearance for its AI-powered software designed to aid in heart failure detection. Echo IQ and the FDA are expected to meet within the next 30 days to discuss the matter. The review is expected to provide greater clarity on the U.S. regulatory path for EchoSolv HF.