CMR Surgical’s Versius surgical robot has received a European CE and UKCA marks for paediatric surgery, unlocking a new market segment for the UK-based company.
Building on the CE mark initially granted to CMR in 2019, the latest approval clears Versius for performing abdominal surgery in children and infants under the age of 18.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Mark Slack, CMR’s chief medical officer, commented: “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.”
Versius is a modular and portable robot designed to give surgeons increased dexterity and precision whilst performing complicated surgical procedural steps.
CMR initiated its first multicentre prospective clinical trial to assess the safety and efficacy of Versius in paediatric surgery in August 2024 at UK National Health Service (NHS) trial sites, including Southampton Children’s Hospital.
With the paediatric CE mark in hand, CMR has become just the third surgical robotics company, alongside Intuitive Surgical and China’s SHURUI Robotics, to attain designation in Europe. In July 2025, Intuitive’s fifth-generation da Vinci robot obtained a CE mark for adult and paediatric use for minimally invasive endoscopic procedures, including abdominopelvic and thoracoscopic surgical procedures.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataCommenting on CMR’s CE mark, Ewan Brownlee, consultant paediatric urologist at Southampton Children’s Hospital and chief investigator for the Versius paediatric trial, said: “In our study, Versius’s 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.”
Outside the US, Versius is claimed to have completed over 40,000 surgical procedures, making it the second most used soft tissue robotic platform globally. Intuitive’s da Vinci line dominates the global surgical robotics market.
CMR also has its eye on the US market, recently stating that it plans to begin its US commercialisation in 2026. Versius received a de novo clearance from the US Food and Drug Administration (FDA) for performing soft tissue cholecystectomy in adults older than 22 years in October 2024, while its next-generation robot, Versius Plus, gained 510(k) clearance with an indication for gallbladder removal procedures in December 2025.
According to GlobalData analysis, the global surgical robotics market is growing at a CAGR of 6.2% and projected to reach a valuation of $16.2bn in 2034, up from $8.89bn in 2024.
