Moon Surgical announced today that it has received clearance from the United States Food and Drug Administration (FDA) for ScoPilot, an AI-powered feature for its Maestro System. This breakthrough represents the first AI application to run intraoperatively on a commercially available surgical robotic platform using NVIDIA Holoscan technology.
ScoPilot enhances surgical procedures by ensuring a stable and optimal view during operations. The technology allows a laparoscope attached to the Maestro System to automatically follow a surgeon's instrument tip, enabling control of laparoscope positioning without requiring the surgeon to disengage from instruments in their hands.
"ScoPilot empowers surgeons to control three instruments with just two hands, while offering a stable, constantly optimal, and safe field of view that is crucial during surgery," said Anne Osdoit, CEO of Moon Surgical and Partner at Sofinnova Partners' MedTech accelerator, MD Start. "The control provided by Maestro's ScoPilot will enhance OR efficiency by making the surgeon more autonomous while improving procedural visualization."
Clinical Implementation and Impact
The Maestro System, which received FDA clearance in June 2024, has already demonstrated significant clinical utility. To date, it has been used in the treatment of over 1,100 patients across the United States and Europe, spanning multiple surgical specialties including general, bariatric, gynecologic, and urologic procedures.
The system's design incorporates extensive ambient sensing capabilities paired with NVIDIA-accelerated computing and AI. This combination generates comprehensive surgical datasets including multi-modal sensing and kinematics, which are driving the development of next-generation Physical AI capabilities to enhance surgical care both in the operating room and throughout the perioperative workflow.
Technical Innovation
ScoPilot runs locally on Moon Surgical's Maestro System and is enabled by NVIDIA Holoscan, a real-time sensing platform specifically designed for developing and deploying AI applications in the operating room. The technology is designed to be on-demand and user-friendly, seamlessly integrating into existing surgical workflows.
Kimberly Powell, Vice President of Healthcare at NVIDIA, highlighted the significance of this achievement: "Moon Surgical's software-defined platform has been a game-changer, driving a continuous stream of pioneering breakthroughs in the surgical robotics industry. With ScoPilot, Moon Surgical has achieved the incredible feat of the first FDA-cleared AI-driven surgical movement natively integrated into a robotics platform and powered by Holoscan."
Future of Surgical Robotics
Founded in 2020, Moon Surgical is a French-American company with offices in Paris, France, and San Francisco, California. The company's mission centers on building "the OR of the future" – one that is digitalized, efficient, and sustainable.
The company's approach combines the Maestro System with Maestro Insights, an intelligent platform that aims to empower healthcare teams to make confident decisions and provide improved surgical care. This integrated approach represents a significant step forward in the evolution of surgical robotics, with AI-enhanced capabilities that could potentially transform surgical procedures across multiple specialties.
The FDA clearance of ScoPilot marks an important milestone in the integration of artificial intelligence into surgical procedures, potentially setting a new standard for how robotic assistance can enhance surgeon capabilities while maintaining workflow efficiency and improving patient outcomes.
As surgical robotics continues to evolve, Moon Surgical's innovations demonstrate how AI can be effectively deployed to address specific challenges in the operating room, particularly in laparoscopic procedures where visualization and instrument control are critical factors in surgical success.
