Moon Surgical receives first FDA 510(k) clearance for its Maestro(TM) Surgical Robotics System

PARIS and SAN FRANCISCO / ACCESSWIRE / December 6, 2022 / Moon Surgical, a French-American pioneer in accessible surgical innovation, announced today the United States Food and Drug Administration (FDA) clearance for its unique Maestro surgical robotics system.

"At Moon Surgical, we are creating a new category of surgical robotics that will change the scale at which robotics can be deployed and enable healthcare providers to do more with the tools they already have," said Anne Osdoit, CEO of Moon Surgical, and a Partner in Sofinnova Partners' medtech accelerator, MD Start. "The clearance of Maestro by the FDA is a significant step forward on this path. It enables select high-volume surgical centers in the U.S. and the patients they serve to gain access to the capabilities offered by Maestro. It will also provide us with invaluable insights about its use in a real life setting."

Maestro is designed to support surgeons and patients in the 18.8 million annual soft tissue surgical procedures not currently supported by telerobotic systems on the market. Maestro is small, adaptable, and can be integrated into existing clinical workflows. Its capabilities can bolster operating room efficiency and allow for alternative labor models.

"We have seen tremendous interest from surgical practices in the U.S. and are eager to see surgeons and their staff using Maestro for the benefit of their patients in that geography," commented Professor Brice Gayet, a visionary laparoscopist and co-founder of Moon Surgical. "Maestro will dramatically change the way in which the standard of care is performed in soft tissue surgery, for millions of patients each year."

Moon Surgical is currently finalizing the development of its first commercial system.

About Moon Surgical

Moon Surgical, based in Paris, France, and in San Francisco, California, believes the future of the operating room lies in the hands of the empowered surgeon.

By equipping surgeons with complete control, renewed confidence, and technology adaptable to any situation they encounter, Moon Surgical strives to improve efficiency in operating rooms and provide better surgical care for patients. The minimalistic, co-manipulation Maestro Robotic System uses tomorrow's technology to deliver these vital skills to surgeons, today.

The company was founded in 2019 by Pr. Brice Gayet and incubated by Sofinnova MD Start.

www.moonsurgical.com

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