Moon Surgical, based in Paris and San Francisco, has achieved FDA clearance to sell its Maestro soft tissue surgical robot commercially in the United States. This move puts Moon in direct competition with Intuitive Surgical's da Vinci system, which currently dominates the market. Moon Surgical plans to conduct a limited launch of the Maestro system in the U.S. and Europe before a broader rollout in 2025.

Moon Surgical believes there is a niche in the market for its system to support laparoscopic surgeries that are not compatible with traditional robot-assisted devices. The company estimates that nearly 19 million additional soft tissue surgical procedures each year could benefit from robotic systems. Laparoscopic procedures involve inserting surgical instruments through small incisions, resulting in shorter patient recovery times.

The Maestro robot by Moon Surgical can seamlessly integrate into existing clinical workflows for various laparoscopic indications, thereby enhancing operating room efficiency. CEO Anne Osdoit mentioned that U.S. medical facilities are eager to participate in the limited market release of the Maestro system.

Osdoit added, "Our Maestro System introduces a new category of robotic surgery tailored for the broad laparoscopy market, enabling robotics utilization on an unprecedented scale."

Having received a CE mark in September 2023, the Maestro system has already treated over 200 patients in general, bariatric, and gynecologic surgery at two European pilot sites. Moon Surgical initially obtained FDA clearance for a noncommercial version of Maestro in December 2022.

Moon Surgical is among several emerging robot makers entering the competitive soft tissue surgery market. For instance, Medical Microinstruments recently received FDA de novo classification for its Symani system in reconstructive microsurgery, while Virtual Incision gained de novo authorization for its Mira robot in colectomy procedures.

While smaller companies strive to catch up to Intuitive Surgical, the market leader has introduced the latest version of its robot, da Vinci 5, marking its first upgrade in a decade.