Saturday, May 31, 2025

Moon Surgical Wins FDA OK for AI-Powered ScoPilot™

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Moon Surgical , a French-American pioneer in surgical innovation, announced U.S. Food and Drug Administration (FDA) approval of ScoPilot. Enabled by NVIDIA Holoscan , a real-time sensing platform designed for the development and deployment of artificial intelligence-based applications in the operating room, running locally on Moon Surgical’s Maestro system, ScoPilot is the first AI application to run intraoperatively on any commercially available surgical robotic platform powered by Holoscan.

ScoPilot is an AI-powered feature of the Maestro system that ensures a stable and ideal view during surgery and is designed to improve control, safety, and efficiency in the operating room. ScoPilot enables the laparoscope connected to a Maestro system to seamlessly follow a desired instrument tip and is easy to use. Surgeons control the positioning of the laparoscope without detaching from the instruments in their hands, allowing them to maintain surgical flow and focus.

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“ScoPilot enables surgeons to control three instruments with just two hands while providing a stable, consistently optimal, and safe field of view, which is critical during surgery,” said Anne Osdoit, CEO of Moon Surgical and partner at Sofinnova Partners’ MedTech accelerator MD Start. “The control capabilities provided by Maestro’s ScoPilot will increase efficiency in the operating room by giving surgeons more autonomy while also improving visualization of the procedure.”

Moon Surgical’s commercial Maestro system, approved by the FDA in June 2024, has already been used to treat more than 1,100 patients in the United States and Europe, spanning general, bariatric, gynecological, and urological surgeries. With its unique and comprehensive environmental sensing, coupled with accelerated NVIDIA computing and AI, Maestro generates an unprecedented surgical dataset with multimodal sensing and kinematics, driving the development of next-generation physical AI capabilities that enhance surgical care both in the operating room and throughout the perioperative workflow.

“Moon Surgical’s software-defined platform has transformed the industry, leading to a continuous stream of groundbreaking breakthroughs in the surgical robotics industry,” said Kimberly Powell , Vice President of Healthcare at NVIDIA. “With ScoPilot, Moon Surgical has accomplished the incredible feat of natively integrating the first FDA-cleared AI-driven surgical motion solution into a robotics platform and powered by Holoscan.”

Source: PRNewswire

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