Moon Surgical Receives FDA Clearance for Maestro™ Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot®
PARIS and SAN FRANCISCO, July 2, 2025 /PRNewswire/ — Moon Surgical, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two major advancements to its Maestro System: connectivity of the platform to power the Maestro Insights product and a Predetermined Change Control Plan (PCCP) to evolve its AI-powered ScoPilot product. With this clearance, Maestro Systems can now have active Wi-Fi and 5G connectivity, enabling seamless data exchange with Maestro Insights—Moon’s cloud-based platform that gives surgical teams and administrators access to actionable insights from procedural data. Through Maestro Insights™, users can track utilization, monitor progress toward individual and facility-wide goals, and manage scheduling and optimize resources and workflows across sites.
