Moon Surgical has announced that its Maestro System is now CE Marked under the Medical Device Regulation (EU) 2017/745.
“This new milestone is a testament to our team’s hard work and dedication, and attests to the effective ramp-up of our manufacturing and quality operations,” said Anne Osdoit, CEO of Moon Surgical, and a Partner in Sofinnova Partners’ medtech accelerator, MD Start. “With the Maestro System, we aim to empower surgeons to perform laparoscopy with greater ease, precision, and control, improving patient outcomes and enhancing the overall surgical experience.”
Thus far, fifty patients in Europe have benefited from a Maestro-assisted surgery in a clinical trial led by Pr. Guy-Bernard Cadière in Brussels, Belgium.
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Globally, over 18 million patients undergo soft tissue procedures annually without the advantages of robotic surgical platforms. With the Maestro System, Moon Surgical is developing a new category of surgery that enhances traditional laparoscopy. Its state-of-the-art surgical assistance platform is specifically designed to augment the precision and control of laparoscopic surgery, supporting high-volume surgeons performing procedures such as cholecystectomy and hernia repairs and more complex multi-quadrant procedures.
Moon Surgical was founded by Professor Brice Gayet, a world-renowned laparoscopic surgeon, and incubated by Sofinnova Partners MD Start in 2020; it has moved swiftly since. The company raised $31m in May 2022, and, shortly after, announced the completion of a First-in-Human study and FDA clearance for an initial version of its Maestro system, in December of 2022.
