Cambridge, UK-based CMR says the authorization paves the way to introduce a next-generation, adaptable, digitally driven surgical robot in the U.S. The company says Versius becomes the first multi-port, soft tissue general robotic-assisted surgical device to gain authorization through the FDA’s de novo process.
Versius delivers assistance in the precise and accurate control of Versius Surgical endoscopic instruments. Its indication covers adult patients (22 years of age and older) eligible for soft tissue minimal access surgery for cholecystectomy.
The small-scale surgical robotic system 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. CMR Surgical designed Versius to enable surgeons to perform more minimal access surgery. Its minimally invasive approach assists surgeons accessing the lungs, thymus and esophagus.
CMR surgical designed Versius to biomimic the human arm. It features 3D HD vision, easy-to-adopt instrument control and a choice of ergonomic working positions. Its open console could potentially reduce stress and fatigue while allowing for clear communication with the surgical team.
Versius won CE mark in 2019 and has completed more than 26,000 surgical procedures to date.
“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 Mark Slack, chief medical officer and co-founder at CMR Surgical. “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.”
How CMR Surgical plans to launch Versius in the U.S.
CMR Surgical says Versius — as a digitally driven system — remains “rooted in continuous innovation.” The company drives this through software, ensuring that customers benefit from the latest technology updates.
The platform features a suite of digital apps to support surgeons, surgical teams and hospitals. Versius delivers real-time insights to improve proficiency and optimize surgical robotic programs.
As CMR brings Versius to customers across the U.S., the company also plans to roll out a state-of-the-art global metrics-based training program. The pathway draws on technology like the Versius Trainer and Versius eLearning platform, plus peer-to-peer education through preceptoring and ongoing guidance and support. The company says this ensures a smooth transition form training to the operating room.
CMR Surgical also added Versius Virtual Reality and Versius Trainer in VR. These enhancements improve training pathway accessibility, the company said.
“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,” said Massimiliano Colella, interim CEO of CMR Surgical. “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.”
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