Moon Surgical receives FDA clearance for Maestro Robotic Surgery System

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Mooon Surgical's Maestro surgical robot

The Maestro digital surgical assistant is designed to be compact and precise. | Credit: Moon Surgical

Moon Surgical announced today that the U.S. Food and Drug Administration has granted clearance for the commercial version of its Maestro surgical robot. The startup said the system can augment the precision and control of laparoscopic surgery.

Moon Surgical — one of 10 surgical robotics companies to follow in 2024 — said it designed Maestro to provide an accessible, enhanced version of traditional laparoscopy.

“Our Maestro System introduces a new category of robotic surgery tailored for the broad laparoscopy market, enabling robotics utilization on an unprecedented scale,” stated Anne Osdoit, CEO of Moon Surgical and a partner at Sofinnova Partners’ medtech accelerator, MD Start. “We enable healthcare providers to enhance existing tools and optimize surgical services with data-driven insights.” 

Founded in 2020, Moon Surgical asserted that it is “building the OR of the future, one that is digitalized, efficient, and sustainable.” The company, which has offices in Paris and San Francisco, claimed that Maestro and Maestro Insights empower healthcare teams to make confident decisions and provide better surgical care for their patients.

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Maestro supports varied surgeries

Maestro is designed to support surgeons and operating room staffers in the $18.8 million annual market for soft-tissue surgical procedures not currently supported by telerobotic systems. The small, adaptable system can integrate into existing clinical workflows, according to Moon Surgical.

In addition, Maestro features capabilities to bolster operating room efficiency, allow for alternative labor models, and shorten procedure duration, the company said. The system includes NVIDIA Holoscan, an edge computing platform that allows for the deployment of real-time algorithms based on artificial intelligence.

Maestro received CE mark approval in Europe for the latest version of Maestro in September 2023. It has been used to treat more than 200 patients in general, bariatric, and gynecologic surgery at two European pilot sites.

Moon Surgical releases to come in the U.S. and Europe

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

“After a fantastic initial experience in Europe in a real-world, multi-specialty setting, we are eager to implement Maestro programs at select US sites over the next few months,” said Fred Moll, a surgical robotics veteran. The co-founder of Intuitive Surgical joined Moon Surgical’s board last year, when the company raised $55.4 million.

“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,” said Osdoit.

Editor’s note: This article is syndicated from The Robot Report sibling site MassDevice.

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