A recent regulatory milestone marks a significant entry for CMR Surgical as its Versius Plus robotic system gains clearance for gallbladder removal procedures in the United States. The FDA’s 510(k) clearance positions the company to bring this next-generation surgical robot to a broader clinical landscape, setting the stage for American hospitals to evaluate new options for minimally invasive surgery. Versius Plus is poised to compete with established surgical systems as operational flexibility and real-time data become increasingly valuable in operating rooms. Healthcare professionals and patients alike may see streamlined workflows, while U.S. healthcare systems gain access to an already globally utilized device.
Previous coverage of CMR Surgical’s original Versius platform centered on its debut approval and modular approach to minimally invasive surgery, with interest largely focused outside the United States. News last year highlighted Versius’s gradual expansion, emphasizing its compact form factor and collaboration with surgical teams. The recent clearance for Versius Plus shifts attention to its advanced imaging capabilities and digital integration, features which were only on CMR’s development horizon a year ago. The new system’s FDA clearance also accelerates competition in the U.S., where existing surgical robots have maintained dominant market shares.
How does Versius Plus address surgical needs?
Developed through input from surgeons and hospital partners, Versius Plus introduces a modular design intended to simplify operating room logistics. Its portability allows hospitals to manage surgical schedules without the need for dedicated staff members to move the robot, providing adaptive support in both robotic and traditional settings. The system also offers flexible port placement, enabling surgeons to tailor their setup according to each patient’s unique requirements.
What features set Versius Plus apart in the U.S. market?
Versius Plus differentiates itself with an integrated visualization system called vLimeLite, supporting real-time Indocyanine Green (ICG) imaging and various visualization modes. Its open console promotes active communication between the operating surgeon and the medical team, supporting collaborative decision-making. The system’s digital ecosystem, including Versius Connect and Versius Team applications, delivers procedural data to both surgeons and hospital administrators for optimizing surgical programs.
How is CMR Surgical planning for wider adoption?
With 40,000 global procedures performed using Versius, CMR Surgical prepares to launch Versius Plus in the U.S. during 2026. The company plans to expand the range of approved procedures beyond gallbladder removal and continue working with healthcare systems to further the reach of robotic-assisted surgery.
“Versius Plus is designed to meet the practical realities of today’s healthcare environment — adaptable to different settings, efficient to integrate, and scalable for long-term growth,”
commented Chris O’Hara, emphasizing ongoing efforts to secure additional indications.
“FDA clearance represents an exciting opportunity to partner with healthcare systems across the U.S.,”
he added, highlighting the potential for broader adoption.
The newly cleared Versius Plus arrives as hospitals across the U.S. seek ways to make surgical care more efficient and accessible. By integrating flexible design and a data-driven approach, CMR Surgical aims to challenge competitors and adapt to diverse hospital environments. For clinical leaders considering robotic surgery programs, understanding system modularity and maximizing data utility will be critical to successful integration. Stakeholders are likely to monitor how Versius Plus’s digital connectivity influences workflow and clinical outcomes long-term. As adoption of surgical robots grows, evaluating cost, compatibility, and training demands will help hospitals make informed choices. Expansion of approved procedures and measurable impact on surgical efficiency and patient recovery will define Versius Plus’s role in the evolving field of minimally invasive surgery.
