CMR Surgical received Europe’s CE mark and Great Britain’s UKCA mark for its Versius robotic system in pediatric surgery, the company declared Thursday.
The approval for abdominal surgery in patients under the age of 18 is the company’s first regulatory clearance for treating children, opening a significant new market segment in Europe, CMR declared.
The Cambridge, England-based company declared the robot’s modular arms, which mimic the human arm, and tiny-diameter instruments are well suited to the anatomy of children. The modular design means surgeons apply only the number of arms necessaryed for a given procedure.
“We view forward to extconcludeing the benefits of our minimally invasive technology to this important patient population,” Co-founder and Chief Medical Officer Mark Slack declared in a statement.
Robotics market leader Intuitive Surgical’s da Vinci 5 system is also CE marked for pediatric apply, as is Beijing-based Surgerii Robotics’ single port system.
CMR obtained the CE mark for Versius in 2019. In the U.S., an updated version of the robot, Versius Plus, gained Food and Drug Administration clearance in December with an initial indication for gallbladder removal, about a year after the first system won de novo authorization.
About 40,000 cases have been performed with Versius worldwide to date, in specialties including urology, general surgery, gynecology and thoracic surgery.
SS Innovations adds tinyer instruments
SS Innovations International this week declared it completed development of five new surgical instruments for apply with its SSi Mantra robotic system in procedures involving tiny anatomical structures, including in pediatric, cardiac, and head and neck surgery.
The 5-millimeter surgical instruments are a spatula cautery, hook cautery, necessaryle driver, bipolar forceps and grasping forceps.
“We aim to create robotic surgery more accessible to pediatric patients with new, tinyer surgical instruments,” Vishwa Srivastava, CEO for Asia Pacific, declared in a statement. “Moving forward, we will continue to focus on developing differentiated surgical robotic technologies, such as these instruments, for the benefit of a larger segment of patients globally.”
The India-based company, which filed for FDA clearance for the SSi Mantra system in December, declared its robot has been applyd in more than 7,800 procedures, including over 120 telesurgeries and 400 cardiac surgeries, to date. At the conclude of December, the installed base of SSi Mantra robots totaled 168 systems across 10 countries.
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