"We are pleased with the results of our second quarter of 2025 especially with our ability to complete our submission of our De Novo application earlier than projected to the US Food and Drug Administration ("FDA"). This FDA submission is a major milestone for Spectral AI and the DeepView System, representing a crucial step toward bringing this innovative diagnostic device to market in the U.S. It provides clinicians with an immediate, data-driven assessment tool designed to assist clinical decision-making ...