Echo IQ Ltd. disclosed that the FDA issued a not substantially equivalent determination for its initial 510(k) submission covering Echosolv HF, an AI-based heart failure clinical decision support software. The outcome delays U.S. commercial clearance. The filing puts the company’s device pathway into a redesign or resubmission phase, where additional evidence may be needed to support claims around performance equivalence to existing predicate solutions. For AI diagnostics, small changes in interpretation and data handling can materially affect whether regulators accept the evidence package. This development underscores how AI-enabled medical device approvals can hinge on regulatory benchmarking, even when model performance appears strong in internal validation.