Clearance covers abdominal surgery in children and infants under the age of 18. It marks the company’s first regulatory nod for treating children.
The Versius robot is a small-scale surgical robotic system with collaborative arms and bedside units for direct patient access. It also features offers of port placement to best suit the needs of each patient. CMR Surgical designed Versius to enable surgeons to perform more minimal access surgery. Its minimally invasive approach assists surgeons in accessing the lungs, thymus and esophagus.
CMR Surgical designed Versius to biomimic the human arm. It features 3D HD vision, easy-to-adopt instrument control and a choice of ergonomic working positions. Its open console could potentially reduce stress and fatigue while allowing for clear communication with the surgical team.
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Versius became the first multi-port, soft tissue general robotic-assisted surgical device to gain clearance through the FDA’s de novo process in 2024. CMR Surgical added FDA clearance for its next-generation Versius Plus system last month.
The system’s latest regulatory nod reflects how its unique design could prove optimal for the pediatric anatomy, thanks to its compact instrument diameter and maximal dexterity.
“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 Mark Slack, chief medical officer at CMR Surgical. “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.”
