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."

Concomitantly, the FDA also cleared a Predetermined Change Control Plan (PCCP) for ScoPilot, the first Physical AI application integrated into the Maestro platform. ScoPilot enables seamless laparoscope control through real-time movement of the surgeon's instruments. The PCCP allows Moon to build, test, and safely deploy evolving versions of ScoPilot more efficiently.

"The PCCP clearance marks a pivotal moment for Physical AI," said Jeff Alvarez, Chief Strategy Officer at Moon Surgical. "It opens the door to an entirely new pace of innovation; allowing us to continuously expand what ScoPilot can do and accelerate how Maestro elevates surgical teams in the OR."

This dual clearance marks an important inflection point in the expansion of Maestro's capabilities, underscoring Moon Surgical's commitment to building the operating room of the future; one that is more efficient, sustainable, and digitalized.

About Moon Surgical 
Moon Surgical is transforming the operating room with Physical AI, seamlessly integrating intelligence and robotics to elevate the capabilities of surgical teams. The Maestro System represents a new category of minimally invasive surgery—expanding the scale at which robotics are delivered into the operating rooms. Instinctive, collaborative, and cost-effective, Maestro empowers teams to deliver exceptional care with greater adaptability and control.

Moon Surgical. Inspiring and Innovating the Art of Surgery. 

Check us out at www.moonsurgical.com or follow us on LinkedIn. 

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