The FDA issued a not substantially equivalent determination for Echo IQ’s initial 510(k) application for Echosolv HF, its AI-based heart failure clinical decision support software, delaying US commercial clearance. Echo IQ said the decision extends the timeline for resubmission or clarification on its evidence package. The setback arrives as regulators and industry increasingly evaluate how AI software performs across sites, patient populations, and evolving clinical workflows—an area where evidence expectations can differ from traditional static medical devices. For Echo IQ, the decision delays adoption and may increase the cost and time needed to address specific FDA concerns. In practical terms, the ruling adds to a growing body of FDA scrutiny around AI algorithms used for clinical decision-making, where performance must be supported with appropriate validation and risk controls across the full intended use environment.