CMR Surgical, a leader in surgical robotics, has achieved a significant milestone with the US Food and Drug Administration’s (FDA) approval of the Versius Surgical System for adult cholecystectomy procedures.
The authorisation means Versius is the first multi-port, soft tissue general surgical robotic-assisted surgical device (RASD) to receive clearance through the FDA’s De Novo pathway.
Globally, Versius ranks as the second most utilised surgical robotic system.
It has facilitated more than 26,000 procedures across Europe, Latin America, Asia, the Middle East and Africa.
Its compact and modular design enhances its portability, making it ideal for diverse healthcare environments.
The Versius system, engineered to emulate the human arm's natural movements, provides surgeons unparalleled dexterity and precision thanks to its small, fully wristed instruments.
The 3D HD visualisation and ergonomic working positions help to reduce surgeon fatigue while fostering effective communication within the OR team. It integrates advanced software for continuous innovation, enabling real-time insights that enhance proficiency and optimise robotic surgical programmes.
Mark Slack, chief medical officer and co-founder of CMR Surgical, said: ‘This is a pivotal achievement for CMR and, more importantly, for the hospitals and patients who will gain increased access to robotic-assisted cholecystectomy procedures. Our compact and portable surgical robot can now address the needs of various care settings across the largest healthcare market in the world.’
As CMR prepares to launch Versius in the US, it will also introduce a global metrics-based training programme. This comprehensive pathway includes resources such as:
• The Versius Trainer
• eLearning modules
• peer-to-peer education
• Innovative virtual reality tools.
All are designed to ensure seamless integration – from training to the operating room.
Massimiliano Colella, CMR Surgical’s interim CEO, said: ‘Gaining FDA authorisation for Versius to be used in cholecystectomy is a crucial advancement in our mission to expand access to minimal access surgery worldwide. The demonstrated value of Versius as a modular system will help hospitals of all sizes enhance their surgical capabilities.’
Erik Wilson, division director and vice chair of surgery at the University of Texas McGovern Medical School at Houston, added: ‘Having been involved in Versius’s development since 2017, I’m thrilled that hospitals across the US can now utilise this next-generation surgical robot. The FDA clearance addresses the limited choices available in robotic systems, paving the way for hospitals to establish soft tissue robotics programmes.’
The introduction of Versius in the US comes at a time of growing demand for flexible surgical robotic solutions. Despite nearly 10 million major operating room procedures performed annually in the US, only about 2.5% are robotic-assisted.
Versius's compact design also has the potential to offer advanced surgical options to patients within their local communities.
Steven D Schwaitzberg, chairman of the Department of Surgery at the University at Buffalo School of Medicine and Biomedical Sciences, said: ‘The expansion of robotic-assisted procedures over the last decade has been remarkable, yet options for robotic systems in the US have remained limited. The FDA marketing authorisation for Versius addresses this gap, offering a compact, modular system that can adapt to various healthcare settings.’
Having previously secured CE Mark approval in 2019, the FDA’s authorisation is the first phase of CMR’s multi-stage strategy to partner with select US hospitals. The approach positions CMR and Versius to enhance their footprint in the US market and expand collaborations with healthcare institutions nationwide.
