Moon Surgical has achieved a significant milestone with the US Food and Drug Administration (FDA) granting 510(k) clearance for two key advancements to its Maestro surgical system.
This dual clearance paves the way for greater connectivity and AI-powered functionality, underscoring the company’s vision for a more efficient, digitalized operating room. The FDA clearance covers the integration of active Wi-Fi and 5G connectivity to power Maestro Insights, Moon’s cloud-based platform that offers surgical teams and administrators actionable procedural data. With Maestro Insights, users can monitor utilization, track progress toward goals, optimize resources, and streamline workflows across facilities.
“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.”
Simultaneously, the FDA approved a Predetermined Change Control Plan (PCCP) for ScoPilot, the AI application integrated into the Maestro platform. ScoPilot allows real-time laparoscope control based on surgeons’ instrument movements. The PCCP clearance will enable Moon Surgical to deploy iterative updates to 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.”
Building on Earlier Milestones
Earlier this month, Moon Surgical announced FDA clearance for the commercial version of Maestro, following its CE mark approval in September 2023. Designed for adaptability, Maestro supports surgeons, operating room staff, and patients across the 18.8 million annual soft tissue procedures not currently served by telerobotic systems. It is small, easy to integrate into existing workflows, and leverages NVIDIA Holoscan for real-time AI algorithms, enhancing intraoperative decision-making.
“At Moon Surgical, we are innovating and inspiring the art of surgery,” Osdoit noted. “Our Maestro System introduces a new category of robotic surgery tailored for the broad laparoscopy market, enabling robotics utilization on an unprecedented scale.”
With over 200 patients treated at European pilot sites in general, bariatric, and gynecologic surgeries, the company now plans a Limited Market Release in the US and Europe ahead of a broader 2025 launch.
Surgical Robot Landscape
Moon Surgical’s achievement comes during a notable period of innovation in surgical robotics. Over the past year, several robotic systems have secured FDA clearance, reflecting growing demand for advanced technologies in the operating room.
Medtronic is seeking multiple US FDA clearances for its Hugo robotic-assisted surgery system. The company is currently trialing the system for urologic (hernia) and gynecologic procedures, strengthening competition in a market historically dominated by Intuitive Surgical’s da Vinci systems. In May 2024, the company announced a prospective, multicenter study evaluating the safety and performance of Hugo RAS in support of an FDA submission.
In May, Monogram Technologies received US FDA 510(k) clearance for its mBôS TKA System for total knee replacements. These developments highlight the rapid evolution of surgical robotics as companies race to offer systems that are more adaptable, cost-effective, and data-driven.
