What is CMR Surgical's Versius robot approved for in Europe?

The Versius robot has received European CE and UKCA marks for performing paediatric surgery on children and infants.

Which other companies offer surgical robots with European paediatric approval?

Besides CMR Surgical, Intuitive Surgical and SHURUI Robotics also have designations for paediatric use in Europe.

When is CMR Surgical planning to enter the US market with Versius?

CMR Surgical plans to begin its US commercialisation efforts with the Versius robot in 2026.

Home / Health / Robot Surgeon Now Operates on Children in Europe

Robot Surgeon Now Operates on Children in Europe

9 Jan

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Summary

Versius robot secured European CE and UKCA marks for paediatric surgery.
CMR Surgical is now one of three companies with such designation in Europe.
The robotic system is used globally, with US commercialization planned for 2026.

Robot Surgeon Now Operates on Children in Europe

CMR Surgical's Versius robotic system has obtained crucial European CE and UKCA marks for paediatric surgery, significantly expanding its market reach. This recent approval permits the Versius robot to conduct abdominal surgeries on patients under the age of 18, marking a substantial advancement for the UK-based company.

With this paediatric designation, CMR Surgical becomes one of only three surgical robotics firms in Europe to achieve such a status, alongside Intuitive Surgical and SHURUI Robotics. The Versius robot, known for its modular design and enhanced surgical precision, has already completed over 40,000 procedures globally outside the US.

The company is actively pursuing further market expansion, with a planned commercial launch in the United States set for 2026. This follows previous de novo clearance from the US FDA for adult soft tissue procedures, indicating a strong future trajectory for Versius in the growing surgical robotics market.