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.

“Connectivity unlocks a new layer of value for our customers,” said Anne Osdoit, CEO of Moon Surgical. “With Maestro Insights, surgical teams gain a clearer understanding of their practice, and hospitals gain the tools to better manage and scale their surgical services. It’s the next step in making data-driven surgery a practical reality.”

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