Moon Surgical receives FDA clearance for ScoPilot™ on Maestro, industry's first AI-enhanced intraoperative capability, powered by NVIDIA Holoscan

PARIS and SAN FRANCISCO, March 18, 2025 /PRNewswire/ -- Moon Surgical, a French-American pioneer in surgical innovation, announced today the United States Food and Drug Administration (FDA) clearance for ScoPilot. Enabled by NVIDIA Holoscan, a real-time sensing platform designed to develop and deploy applications based on Artificial Intelligence in the operating room, and running locally on Moon Surgical's Maestro System. ScoPilot is the first AI application to run intraoperatively on any commercially available surgical robotic platform with Holoscan.

ScoPilot is an AI-powered feature on the Maestro System that ensures a stable and ideal view during surgery and aims to enhance control, safety, and efficiency in the operating room. On-demand and easy to use, ScoPilot allows the laparoscope attached to a Maestro System to follow a desired instrument tip seamlessly. The surgeon controls laparoscope positioning, without disengaging from the instruments in their hands, helping maintain surgical flow and focus.

"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 a 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."

Moon Surgical's commercial Maestro System, FDA-cleared in June 2024, has been used to treat over 1,100 patients across the United States and Europe, spanning general, bariatric, gynecologic, and urologic surgeries. With its unique and extensive ambient sensing, paired with NVIDIA-accelerated computing and AI, Maestro generates an unprecedented surgical dataset including multi-modal sensing and kinematics— thereby driving the development of next-generation Physical AI capabilities that enhance surgical care both in the operating room and across the broader perioperative workflow.

"Moon Surgical's software-defined platform has been a game-changer, driving a continuous stream of pioneering breakthroughs in the surgical robotics industry," said Kimberly Powell, vice president of healthcare at NVIDIA. " 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."

About Moon Surgical

Moon Surgical, based in Paris, France, and San Francisco, California, is building the OR of the future, one that is digitalized, efficient, and sustainable. The combined power of the transformative Maestro System and the intelligent Maestro Insights empowers healthcare teams to make confident decisions and provide better surgical care for their patients. Founded in 2020, Moon Surgical prides itself on staying nimble, prioritizing innovation, and fostering inclusivity, creativity, and collaboration among its multi-cultural team members.

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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