Moon Surgical has one main goal, according to CEO Anne Osdoit: to build the operating room of the future — one that is efficient, sustainable and digitized.
This month, the robotics startup, which is based in Paris and San Francisco, got a bit closer to achieving this mission by receiving FDA clearance for the commercial version of its Maestro surgical robot system.
The digital surgical assistant is designed to support surgeons and other operating room staff, specifically for the 18.8 million annual soft tissue surgical procedures not currently supported by available telerobotic systems, Osdoit explained.
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“We seek to fill this existing gap in healthcare by introducing a small and adaptable system which seamlessly integrates into existing clinical workflows for any soft tissue laparoscopic indication,” she stated. “This will empower more surgeons, in more facilities, across a variety of specialties to make more confident decisions and provide better surgical care for their patients.”
The Maestro digital surgical assistant consists of one compact unit (a base and two arms) that can be easily rolled into any operating room, Osdoit explained. The unit sits at the bedside on any side the surgeon prefers, depending on the type of procedure.
The device’s robotic arms can hold and manipulate any currently available 5mm and 10mm off-the-shelf surgical instruments. This simplifies the device’s adoption by preserving the existing clinical practice, Osdoit pointed out.
Surgical staff members are free to manually adjust one or both arms at any time during the operation, or they can do so through the user interface, she added.
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Osdoit also noted that the system is equipped with 5G integration, thus allowing for surgical data transmission and insight generation in the cloud. This means that surgeons can access, analyze and act on data collected during each procedure.
“This news proves that while surgical innovation is moving at a fast pace, there’s room for those who have an idea that addresses a pain point within the market,” Osdoit stated. “This is true surgical innovation, an idea that turns into a prototype, that turns into a marketable device that fills a need. This is not innovation for the sake of innovating — this is a solution.”
Moon Surgical’s new FDA clearance is an advancement from the Maestro’s earlier FDA clearance in December 2022, she remarked. The new clearance includes additional capabilities that weren’t there for the first clearance, she said.
“These capabilities were carefully developed to provide more control and confidence to surgeons and their OR teams. Feedback from our first-in-human study was taken into account,” she explained.
For instance, the system can now guide surgical teams to achieve precise system placement next to the bed, thanks to two onboard cameras. The device now also provides a hold confirmation to inform the surgeon once the Maestro has taken over control of the instrument, which helps the surgeon stay focused on the screen, Osdoit explained.
Currently, Moon Surgical is still a pre-revenue company. Its recent FDA clearance is a key part of the startup’s goal to begin the limited market release of the commercial Maestro system in the U.S., Osdoit declared.
“So far, most of the patients treated using the Maestro have been in Europe where the Maestro system carries the CE mark. Now, we are excited to finally be able to offer this innovative technology to our U.S. surgeons and their patients, across a wide range of procedures in general, bariatric and gynecological laparoscopic surgery,” she said.
She noted that transitioning into a commercial stage company in the U.S. is an important inflection point for any new company — especially for one like Moon Surgical that began operating just three and a half years ago.
Photo: Michael Burrell, Getty Images
