CMR Surgical has received CE and UKCA marks for its Versius surgical system in pediatric surgery, marking the company’s first regulatory nod for treating children. The approval was earned for abdominal surgery in children and infants under 18 years old.

Versius’ compact and modular design lets the system be set up in a manner that allows optimal access for the surgeon and surgical teams, the company said. It has a compact instrument diameter and maximal dexterity, making it optimally designed for pediatric surgery.

The system’s portability also allows it to integrate into virtually any operating room and be easily moved between departments, CMR Surgical said.

“Securing CE Mark approval for Versius in pediatric surgery is an important milestone for CMR Surgical and for the future of robotic-assisted minimally invasive surgery,” said CMR Surgical chief medical officer Mark Slack. “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 versatile, adaptable surgical robot that was designed to easily integrate into any operating room and hospital workflow. The system has performed about 40,000 surgical cases to date and is being used across urology, general surgery, gynecology, and thoracic surgery.

“As a pediatric surgeon, I’m delighted that Versius can now benefit more children in the UK and internationally,” said Ewan Brownlee, consultant pediatric urologist at Southampton Children’s Hospital and chief investigator for the Versius Pediatric Trial. In our study, its modular arms and small instruments proved well suited to pediatric anatomy, and we have already completed almost 150 procedures across three centers 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.”

Last month, CMR Surgical won U.S. Food and Drug Administration (FDA) 510(k) clearance for its second-gen Versius Plus robot for cholecystectomy procedures.