The Cambridge, UK-based company seeks clearance for use of the robot in benign gynecology procedures. These could include total hysterectomy, oophorectomy, salpingectomy and other procedures.
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 added FDA clearance for its next-generation Versius Plus system in cholecystectomy in December 2025.
CMR Surgical designed is a small-scale surgical robotic system that features collaborative arms and bedside units for direct patient access. It also features offers of port placement to best suit the needs of each patient. 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.
Learn more about CMR Surgical and the fast-growing surgical robotics space in our 2026 MassDevice Surgical Robotics Special Report. Download the report for free here.
According to CMR Surgical, Versius is the second-most utilized surgical robot globally outside the U.S, with Intuitive Surgical remaining the market leader. Last month, the company said Versius has now treated more than 45,000 patients worldwide ahead of its commercial expansion.
To date, the company says gynecologic procedures represent a large proportion of all Versius cases around the world. It now hopes to bring this to the U.S. market as well.
The robot has been adopted in hospitals across more than 30 countries as CMR turns its focus to the U.S.
“It is an exciting time for CMR as we seek to expand into gynecology in the U.S. and accelerate access to robotic-assisted surgery with Versius Plus in the largest surgical robotic market in the world,” said Massimiliano Colella, CEO at CMR Surgical. “We already have extensive global experience across gynecology and other specialties, and this submission reflects our commitment to bringing a versatile, surgeon-centric solution to more hospitals and healthcare systems in the United States.”
