Moon Surgical Wins FDA Nod for NVIDIA Holoscan-Powered ScoPilot Tool

Moon Surgical has received U.S. Food and Drug Administration (FDA) clearance for ScoPilot.

ScoPilot is enabled by NVIDIA Holoscan, a real-time sensing platform to develop and deploy applications based on artificial intelligence (AI) in the operating room, and running locally on Moon Surgical’s Maestro surgical robotics system.

The AI-powered feature on the Maestro system ensures a stable, ideal view during surgery and aims to boost control, safety, and efficiency in the OR. It allows the laparoscope attached to Maestro to follow a desired instrument tip. The surgeon controls laparoscope positioning without disengaging from the instruments in their hands to maintain surgical flow and focus.

The Maestro system was FDA cleared in June 2024. It’s been used to treat over a thousand patients in the U.S. and Europe, spanning general, bariatric, gynecologic, and urologic surgeries.

Its ambient sensing, paired with NVIDIA-accelerated computing and AI, generates a surgical dataset that includes multimodal sensing and kinematics. This drives next-gen physical AI capabilities that augment surgical care in the OR and across the broader perioperative workflow, according to the company.

“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 software-defined platform has been a game-changer, driving a continuous stream of pioneering breakthroughs in the surgical robotics industry,” added Kimberly Powell, VP 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.”