Moon Surgical wins FDA clearance for commercial surgical robot

Moon Surgical announced today that it received FDA clearance for the commercial version of its Maestro surgical robot system.

Paris-based Moon Surgical — one of MassDevice’s 10 surgical robotics companies you need to know in 2024 — designed Maestro to provide an accessible, enhanced version of traditional laparoscopy. Maestro acts as a robotic surgical assistant to augment the precision and control of laparoscopic surgery. The small, adaptable system can integrate into existing clinical workflows. It features capabilities that bolster operating room efficiency and allow for alternative labor models.

The system features Nvidia Holoscan, an edge computing platform that allows for the deployment of real-time algorithms based on AI. This provides immediate benefits in the operating room during surgery, according to a news release.

Maestro received CE mark approval in Europe for the latest version of Maestro in September 2023. Its uses span more than 200 patients in general, bariatric and gynecologic surgery at two European pilot sites.

Moon Surgical now plans to deploy Maestro in the U.S. and Europe through a limited market release. It anticipates a broader launch in 2025.

Fred Moll, a surgical robotics veteran, joined Moon Surgical’s board last year. He said the company is “eager to implement” Maestro across select U.S. sites in the next few months.

“Our Maestro system introduces a new category of robotic surgery tailored for the broad laparoscopy market, enabling robotics utilization on an unprecedented scale. We enable healthcare providers to enhance existing tools and optimize surgical services with data-driven insights,” said Anne Osdoit, CEO of Moon Surgical. “This clearance is very timely and will bolster the remarkable traction we’ve had following the recent SAGES conference, with U.S. sites eagerly lining up to join our limited market release.”