Echo IQ disclosed that the U.S. FDA issued a not substantially equivalent determination for its initial 510(k) submission for Echosolv HF, delaying U.S. commercial clearance for the company’s AI-based heart failure decision support software. The response means the pathway for clearance will likely require additional evidence or a revised submission. For the AI in healthcare segment, the case highlights recurring friction points in medtech regulation: aligning outputs with predicate devices, establishing performance in intended-use settings, and demonstrating robust equivalence when models evolve. Near-term, the decision may slow adoption among hospitals and test how quickly developers can iterate to meet FDA expectations for AI-enabled clinical tools.