~ Following Recent FDA Clearance for Cholecystectomy, the Company is now 510(k) pending for Gynecology. This Submission Builds On Extensive Global Clinical Experience in Gynecology and Continues CMR’s U.S. Market Expansion
CAMBRIDGE, UK, April 29, 2026 — CMR Surgical, a global medical technology business, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for its Versius Plus™ Surgical Robotic System. The submission seeks clearance to market the device for benign gynecology procedures such as total hysterectomy as well as oophorectomy, salpingectomy, and other gynecologic procedures.
Versius is currently the second most utilized surgical robotic system globally outside of the United States, with growing adoption across multiple specialties, including gynecology. To date, gynecologic procedures represent a large proportion of all Versius cases recorded globally, reflecting strong clinical uptake and surgeon confidence.
Massimiliano Colella, Chief Executive Officer at CMR Surgical said: “It is an exciting time for CMR as we seek to expand into gynecology in the U.S. and accelerate access to robotic-assisted surgery with Versius Plus in the largest surgical robotic market in the world. We already have extensive global experience across gynecology and other specialties, and this submission reflects our commitment to bringing a versatile, surgeon-centric solution to more hospitals and healthcare systems in the United States.”
Versius Plus, an adaptable and versatile modular system, gives surgeons the flexibility to use familiar laparoscopic port placement with the precision of fully wristed instrumentation compatible with 5mm-ports, and advanced 3D visualization on a digitally integrated robotic platform.
The news follows CMR’s announcement that over 45,000 patients have now been treated globally using the Versius Surgical Robotic System.
Robotic-assisted surgery continues to play an expanding role in gynecology, helping surgeons deliver minimally invasive care with potential benefits including reduced hospital stays, faster recovery, and improved patient outcomes.
The company’s approach reflects a responsible, evidence-based regulatory progression, building on its initial U.S. authorization and global clinical experience.
CMR Surgical will participate in the upcoming American College of Obstetricians and Gynecologists Annual Meeting, where it will engage with the gynecologic community and share insights from its global experience in robotic-assisted surgery.
CMR Surgical (CMR) is a global medical devices company dedicated to transforming surgery with Versius Plus, a next-generation surgical robot. Headquartered in Cambridge, United Kingdom, CMR is committed to working with surgeons, surgical teams and hospital partners, to provide an optimal tool to make robotic minimal access surgery universally accessible and affordable. With Versius Plus, CMR Surgical is on a mission to redefine the surgical robotics market with practical, innovative technology and data that can improve surgical care. Founded in 2014, CMR Surgical is a private limited company backed by an international shareholder base.
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