News

CMR Surgical has revealed that it has secured CE and UKCA Marks for its Versius Surgical System (Versius) for use in paediatric surgery, representing the Company’s first regulatory approval for treating children. The clearance covers abdominal procedures in children and infants up to the age of 18.

Versius features a highly compact and modular architecture, enabling flexible set-up to provide surgeons and operating teams with optimal access. Its small instrument diameter combined with high dexterity makes the system particularly well suited to paediatric anatomy. In addition, Versius’ portability allows it to integrate easily into almost any operating theatre and to be transferred smoothly 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 distinctive, flexible and highly adaptable robotic surgical system designed to integrate smoothly into existing operating rooms and hospital workflows. To date, the system has been used in approximately 40,000 surgical procedures and is deployed across multiple specialties, including urology, general surgery, gynaecology and thoracic surgery, in leading hospitals worldwide. Its mobility allows it to be shared across departments, supporting a wide spectrum of care settings, from high-volume, low-acuity procedures to complex oncological surgeries.