CMR Surgical receives CE Mark for use of Versius in paediatric surgery

• Small, modular design of the Versius system supports use in robotic-assisted paediatric surgery
  
  

Cambridge, UK – 8 January 2026, CMR Surgical (‘CMR’ or ‘the Company’), the global surgical robotics business, today announces that it has received CE and UKCA Marks for its Versius Surgical System (Versius) in paediatric surgery, marking the Company’s first regulatory clearance for treating children. The approval has been received for abdominal surgery in children and infants under the age of 18.

Versius’ uniquely compact and modular design allows the system to be set up in a way that enables optimal access for the surgeon and surgical teams. With a compact instrument diameter and maximal dexterity, the system is optimally designed for the paediatric anatomy. The system’s portability allows it to seamlessly integrate into virtually any operating room and be easily moved between departments.

Mark Slack, Chief Medical Officer at CMR Surgical, commented: “Securing CE Mark approval for Versius in paediatric surgery is an important milestone for CMR Surgical and for the future of robotic-assisted minimally invasive surgery. The approval opens a new, high value segment of the market, whilst validating the strength and flexibility of our technology and we look forward to extending the benefits of our minimally invasive technology to this important patient population.”

Ewan Brownlee, Consultant Paediatric Urologist at Southampton Children’s Hospital and Chief Investigator for the Versius Paediatric Trial, said: “As a paediatric surgeon, I’m delighted that Versius can now benefit more children in the UK and internationally. In our study, its modular arms and small instruments proved well suited to paediatric anatomy, and we have already completed almost 150 procedures across three centres in patients from just a few months old upwards. With approval for use in under-18s, we will be able to extend the benefits of minimally invasive surgery to a wider patient population.”

Versius is a unique, versatile and adaptable surgical robot designed to seamlessly and easily integrate into any operating room and hospital workflow. The system has performed c.40,000 surgical cases to date and is being used across a broad range of specialties including urology, general surgery, gynaecology, and thoracic surgery in leading hospitals around the world. Versius can be easily moved between departments, making it suitable for any care setting from low acuity, high-volume cases to the most complex oncological surgical procedures.

Media Contacts:

ICR Healthcare

Mary-Jane Elliot / Angela Gray / Jonathan Edwards

CMRSurgical@icrhealthcare.com

Notes to editors:

The Versius Surgical Robotic System

Versius resets expectations of robotic surgery. Versius fits into virtually any operating room set-up and integrates seamlessly into existing workflows, increasing the likelihood of robotic minimally invasive surgery (MAS). The small, portable and modular design of Versius allows the surgeon to only use the number of arms needed for a given procedure.

Biomimicking the human arm, Versius gives surgeons the choice of optimised port placement alongside the dexterity and accuracy of small fully wristed instruments. With 3D HD vision, easy-to adopt instrument control and a choice of ergonomic working positions, the open surgeon console has the potential to reduce stress and fatigue and allows for clear communication with the surgical team. By thinking laparoscopically and operating robotically with Versius, patients, surgeons and healthcare professionals can all benefit from the value that robotic MAS brings.

But it’s more than just a robot. Versius captures meaningful data with its wider digital ecosystem to support a surgeon’s continuous learning. Through the Versius Connect app, Versius Trainer and CMR clinical registry, Versius unleashes a wealth of insights to ultimately improve surgical care.

About CMR Surgical Limited

CMR Surgical (CMR) is a global medical devices company dedicated to transforming surgery with Versius, 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 minimally invasive surgery universally accessible and affordable. With Versius, we are 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.