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Moon Surgical receives second FDA approval for Maestro system
Moon Surgical, a French-American innovator in the field of surgical technology, has received FDA clearance for the commercial release of its Maestro surgical system.
"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 utilisation on an unprecedented scale. We enable healthcare providers to enhance existing tools and optimise surgical services with data-driven insights," said Anne Osdoit, CEO of Moon Surgical, and a Partner at Sofinnova Partners' medtech accelerator, MD Start. "This clearance is very timely and will bolster the remarkable traction we've had following the recent SAGES conference, with US sites eagerly lining up to join our Limited Market Release."
Maestro is engineered to enhance support for surgeons, operating room staff, and patients in the 18.8 million annual soft tissue surgeries that current telerobotic systems do not assist. Compact and highly adaptable, the Maestro system integrates effortlessly into existing clinical workflows for various laparoscopic procedures. Its advanced features are designed to improve operating room efficiency, enable alternative staffing models, and ensure shorter, more predictable surgical durations. The system incorporates NVIDIA Holoscan, a robust edge computing platform that utilises real-time AI algorithms to deliver immediate, in-surgery benefits.
"The team at Moon Surgical has been impressively delivering on schedule while adding resources to get ready for its commercial phase," commented Fred Moll, Chair of the Moon Surgical board. "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."
The Maestro system secured its CE mark in September 2023 and has since been utilised in over 200 surgeries, including general, bariatric, and gynecologic procedures, at two pilot sites in Europe.