CMR Surgical has earned U.S. Food and Drug Administration (FDA) de novo clearance for its Versius surgical system.
 
Versius is touted as the first multi-port, soft tissue general surgical robotic-assisted surgical device (RASD) to be successfully authorized through the FDA’s de novo pathway. The Versius RASD assists in the precise, accurate control of the Versius endoscopic instruments.
 
It’s indicated in the U.S. for patients 22 years and older, eligible for soft tissue minimal access surgery, for cholecystectomy.
 
The Versius robot is compact and modular, meaning it can integrate into virtually any operating room for cholecystectomy procedures, the company said. It’s designed to mimic the human arm and features small, fully wristed instruments.
 
Versius also features 3D HD vision, instrument control, and a choice of ergonomic working positions. Its open surgeon console aims to reduce stress and fatigue, while allowing clear communication with the surgical team. A suite of digital apps to support surgeons, surgical teams and hospitals also provides insights to improve efficiency and optimize surgical robotic programs.
 
CMR said it will roll out a global, metrics-based training program for Versius. The training pathway leverages the company’s Versius Trainer and eLearning platform, as well as peer-to-peer education through preceptoring and ongoing guidance and support. The training pathway also features Versius virtual reality and Versius Trainer in VR.
 
Versius could enable patients to undergo minimal access surgery for cholecystectomy procedures closer to home thanks to this compact, modular, portable system. The FDA authorization of Versius is the first part of a multi-stage strategic plan that will involve initially partnering with a select number of U.S. hospitals.
 
“Securing FDA marketing authorization for Versius for use in cholecystectomy in adult patients is a significant milestone for CMR and, most importantly, for hospitals and patients who will now have greater access to robotic-assisted surgery in cholecystectomy procedures,” said CMR Surgical co-founder and chief medical officer Mark Slack. “With FDA authorization, we can now bring our compact and portable surgical robot to the world’s largest healthcare market, expanding the benefits of robotic-assisted surgery with Versius across various care settings in the U.S.”
 
“The U.S. is an important strategic market so gaining FDA authorization for Versius for use in cholecystectomy procedures in adult patients is a significant step forward in CMR achieving its mission of bringing minimal access surgery to more patients around the world,” added CMR interim CEO Massimiliano Colella. “The value of Versius as a compact and modular system has been demonstrated by leading hospitals around the world, and we look forward to working closely with hospitals in the U.S. to introduce Versius.”
 
Last week, the company revealed former CEO Supratim Bose stepped down due to personal reasons. Colella was named interim CEO during the announcement.