CMR Surgical Seeks FDA Clearance to Expand Versius Plus into U.S. Gynecology Market

New updates have been reported about CMR Surgical.

CMR Surgical has filed a 510(k) premarket notification with the U.S. Food and Drug Administration seeking clearance to use its Versius Plus surgical robotic system in benign gynecology, including total hysterectomy, oophorectomy, salpingectomy, and related procedures. This move follows recent FDA clearance for Versius Plus in cholecystectomy and is a key step in broadening the platform’s clinical indications in the world’s largest surgical robotics market.

The company positions Versius Plus as a modular, laparoscopic-friendly system offering fully wristed instruments compatible with 5 mm ports and advanced 3D visualization on a digitally integrated platform, aiming to appeal to hospitals seeking flexible capital deployment and workflow compatibility. Versius is already the second most widely used surgical robotic system globally outside the U.S., with gynecology accounting for a significant share of its more than 45,000 recorded cases, which provides CMR with a substantial clinical evidence base to support the new submission.

CEO Massimiliano Colella framed the filing as part of an accelerated U.S. expansion strategy, leveraging established international experience in gynecology and other specialties to build surgeon confidence and support adoption in American hospitals and health systems. Regulatory progress in gynecology is strategically important because robotic-assisted minimally invasive procedures in this field continue to grow, driven by potential benefits such as shorter hospital stays, quicker recovery, and improved outcomes, which align with provider cost and quality metrics.

CMR plans active engagement with the U.S. gynecologic community, including participation in the American College of Obstetricians and Gynecologists Annual Meeting, to reinforce its positioning and capture early adopter interest as it awaits FDA feedback. While the timing and outcome of the 510(k) review remain uncertain, successful clearance would materially expand Versius Plus’s addressable U.S. procedure volume, strengthen CMR’s competitive stance against incumbent robotic platforms, and support its broader ambition to redefine the surgical robotics market with a scalable, data-enabled ecosystem.