Moon Surgical’s Commercial Maestro Robot Wins FDA Nod

Moon Surgical has gained U.S. Food and Drug Administration (FDA) clearance for the commercial version of its Maestro surgical robotic system.
 
Maestro aims to support the 18.8 million annual soft tissue surgeries not supported by available telerobotic systems. It’s small, adaptable, and integrates into clinical workflows over any laparoscopic indication, according to the company.
 
The system comes equipped with NVIDIA Holoscan, an edge computing platform that allows real-time algorithms based on artificial intelligence (AI) to be used in the operating room. The Maestro system received CE mark clearance in September 2023.
 
“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 utilization on an unprecedented scale. We enable healthcare providers to enhance existing tools and optimize 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 U.S. sites eagerly lining up to join our limited market release.”
 
To date, Maestro has treated over 200 patients in general, bariatric, and gynecologic surgery at two European pilot sites.
 
“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 U.S. sites over the next few months.”
 
In April, the Maestro system’s was broadened to laparoscopic hysterectomy, cystectomy, adnexectomy, and ovariectomy procedures.