Moon Surgical Earns 2 FDA Nods for Maestro Surgical Robot

Moon Surgical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for two advancements to its Maestro robotic surgical 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.

Thanks to this FDA nod, Maestro systems can now have active Wi-Fi and 5G connectivity for seamless data exchange with Maestro Insights, the company’s cloud-based platform that provides actionable insights from procedural data. Using the tool, users can track utilization, monitor progress toward individual and facility-wide goals, and manage scheduling and optimize resources.

“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.”

The FDA also cleared a PCCP for ScoPilot, the first Physical AI application integrated into the Maestro platform. ScoPilot allows laparoscope control through real-time movement of surgical instruments. The PCCP lets Moon 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.”