French-American medical technology company Moon Surgical has received FDA clearance for the commercial version of its Maestro robotic surgery system, paving the way for the system's deployment in the U.S. and Europe through a Limited Market Release ahead of a broader launch in 2025.

The Paris- and San Francisco-based company aims to revolutionize laparoscopic surgery with its Maestro system, designed to enhance efficiency and support operating room teams in performing the 18.8 million annual soft tissue surgical procedures not currently addressed by existing telerobotic systems. Anne Osdoit, CEO of Moon Surgical and partner at Sofinnova Partners' medtech accelerator, MD Start, emphasized the system's potential to optimize surgical services through data-driven insights and integration into existing clinical workflows.

"At Moon Surgical, we are innovating and inspiring the art of surgery. Our Maestro System introduces a new category of robotic surgery tailored for the broad laparoscopy market, enabling robotics utilization on an unprecedented scale," Osdoit said. "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."

The Maestro system, equipped with NVIDIA Holoscan for real-time AI algorithm deployment, aims to improve operating room efficiency, enabling alternative labor models and more predictable procedure durations. The system has been used to treat over 200 patients across various specialties, including general, bariatric, and gynecologic surgery, at two pilot sites in Europe since obtaining CE mark approval in September 2023.

Moon Surgical was founded in 2020 with a vision to build a digitalized, efficient, and sustainable operating room. The company prides itself on innovation and fostering a collaborative, multicultural team environment.

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