CMR Surgical's Versius Receives First FDA Approval
21 OCTOBER 2024
The U.S. Food and Drug Administration has granted the Versius robotic surgery system its first approved use in the United States. This comes through a "limited marketing authorization through the FDA’s De Novo process which establishes initial indication for adults undergoing cholecystectomy," according to a CMR Surgical release (link below)
The company release continues: "...The FDA marketing authorization of Versius is a significant milestone for CMR as Versius is the first multi-port, soft tissue general surgical Robotic Assisted Surgical Device (RASD) to successfully be authorized through FDA’s De Novo application process. Versius is a RASD intended to assist in the precise and accurate control of Versius Surgical endoscopic instruments and is indicated in the U.S. for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy."
The U.K. company received clearance for use of the robot in Europe in 2019. CMR Surgical will be working first with select U.S. hospitals as part of their plan to expand within the U.S. market.
