CMR Surgical receives CE Mark for use of Versius in paediatric surgeryCMR Surgical receives CE Mark for use of Versius in paediatric surgery
CMR Surgical receives U.S. FDA Marketing Authorization for next-generation Versius Surgical SystemCambridge, UK – 15 October 2024, 12:00 (BST). CMR Surgical (CMR or ‘the Company’), a global surgical robotics business, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the Versius Surgical System (Versius), paving the way for a next-generation versatile, adaptable, and digitally driven surgical robot to be introduced in the United States. 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.
CMR Surgical hires industry leader to drive operations across Asia Pacific, the Middle East and AfricaCMR Surgical hires industry leader to drive operations across Asia Pacific, the Middle East and Africa
Veteran MedTech leader and hospital group CEO joins CMR Surgical as global Chief Commercial OfficerVeteran MedTech leader and hospital group CEO joins CMR Surgical as global Chief Commercial Officer
Versius used to perform over 10,000 casesVersius used to perform over 10,000 cases
