Moon Surgical's robotic OR helper gets commercial green light from FDA

It’s all systems go for Moon Surgical with a new FDA green light for its Maestro robotic laparoscopy platform.

The company said it will now begin deploying its surgical assistant in the U.S. through a limited rollout—while also expanding its reach in Europe, where it received a CE mark approval in September 2023. The countdown for a broader commercial launch will extend into 2025.

Maestro aims to help surgeons by providing two flexible arms that can be used to hold minimally invasive instruments and cameras in place during a procedure. The robotic appendages can be manipulated by hand and paired with nearly any off-the-shelf laparoscopic tool.

Moon Surgical Maestro robotic assistant
The Maestro (Moon Surgical)

“Our Maestro System introduces a new category of robotic surgery tailored for the broad laparoscopy market, enabling robotics utilization on an unprecedented scale,” CEO Anne Osdoit said in a statement. Osdoit is also a partner at Moon backer Sofinnova Partners and its medtech accelerator, MD Start.

The former Fierce 15 winner estimates that Maestro will be able to tap into the nearly 18.8 million soft tissue surgeries that are conducted each year without any available robotic support, by being able to adapt to current workflows. The platform also links with Nvidia’s Holoscan artificial intelligence software for charting operating room data.

Moon previously received an initial FDA 510(k) clearance for Maestro in late 2022; the latest regulatory nod covers the new commercial version of the system. 

Based in Paris and San Francisco, the company said earlier this year that Maestro has been used in more than 200 patients across bariatric, gynecologic and general surgery procedures, through two European pilot sites.

“After a fantastic initial experience in Europe in a real-world, multi-specialty setting, we are eager to implement Maestro programs at select U.S. sites over the next few months,” said Fred Moll, M.D., chair of Moon’s board of directors.