Versius Plus received clearance for cholecystectomy (gallbladder removal) procedures. The latest regulatory nod comes just over a year after Versius became the first multi-port, soft tissue general robotic-assisted surgical device to gain clearance through the FDA’s de novo process. It also comes shortly after Medtronic, another potential competitor to surgical robotics leader Intuitive, earned its first FDA nod for its Hugo robot.
Cambridge, U.K.–based CMR says Versius Plus represents a new market offering with its flexible, modular design and data-driven digital ecosystem. The company said it brings next-generation innovation to the operating room for both surgeons and the entire OR team.
Versius Plus features an open console to facilitate communication between the surgeon and other medical professionals. It aims to support real-time decision-making.
With this clearance, CMR Surgical expects to begin Versius Plus commercialization in 2026.
“This 510(k) clearance represents an exciting new chapter for CMR Surgical as we introduce Versius Plus to the U.S. market. Built on years of global clinical use data, Versius Plus delivers the flexibility and intelligence today’s healthcare institutions need to advance robotic-assisted surgery,” said Massimiliano Colella, CMR Surgical CEO. “It’s inspiring to see our new technology transforming the landscape of surgical care.”
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More about the CMR Surgical Versius Plus robot
CMR Surgical has previously described its original Versius robot as a small-scale surgical robotic system with 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.
Versius was designed 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.
CMR Surgical says Versius Plus also features a compact, modular design for easy movement between departments and ORs. Hospitals can seamlessly switch between robotic and non-robotic procedures in the same space. Meanwhile, surgeons can benefit from flexible port placement, choosing the setup that best fits their patient and technique.
Alongside a full surgical toolkit, Versius Plus also features integrated fluorescence visualization, called vLimeLite. This enables real-time ICG imaging for multiple visualization modes, with overlay and grayscale options.
CMR Surgical also offers Versius Connect, a dedicated surgeon app with a near-real-time logbook of procedures. Its Versius Team live dashboard tracks usage, case volume and system efficiency to help optimize robotic programs.
“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,” said Chris O’Hara, president & GM, U.S. at CMR Surgical. “FDA clearance represents an exciting opportunity to partner with healthcare systems across the U.S. Versius Plus is designed to support a broad range of soft-tissue procedures, and we are diligently advancing additional indications in the U.S. and aim to help make robotic-assisted surgery more accessible than ever before.”
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