CMR Surgical Secures 510(K) Clearance Of Its Versius Plus Robotic Surgical System

CMR Surgical secures 510(k) clearance of its Versius Plus robotic surgical system

• Regulatory clearance of CMR's most advanced system paves the way for upcoming US commercial launch
• Strong clinical interest received from US surgeons nationwide for the system

CMR Surgical, a global medical technology company, today announces its second-generation surgical robotic platform, Versius Plus, has received 510(k) clearance from the United States Food and Drug Administration (FDA) for cholecystectomy procedures.

With a flexible, modular design and data-driven digital ecosystem, Versius Plus represents a new market offering, providing more choice for surgeons and hospitals. The system brings next-generation innovation to the operating room, designed not only for the surgeon but for the entire OR team. Its open console facilitates communication between the surgeon and other medical professionals, which supports real-time decision making.

The FDA previously granted marketing authorization for CMR's first-generation Versius Surgical System through the De Novo process in October 2024. With the 510(k) clearance of Versius Plus, CMR is on track to begin commercialization in 2026.

Outside of the United States, CMR's robotic surgical platforms have already completed over 40,000 surgical procedures, establishing a strong foundation for their performance across multiple specialties and care settings, and making the soft tissue robotic platforms the second most utilized globally.

Massimiliano Colella, Chief Executive Officer at CMR Surgical, commented:
“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. It's inspiring to see our new technology transforming the landscape of surgical care.”

Chris O'Hara, President & General Manager US at CMR Surgical, commented:
“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. 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.”

Key Benefits of Versius Plus

Adaptable

Owing to its compact, modular design, Versius Plus moves easily between departments and operating rooms – with no dedicated OR required. Hospitals can seamlessly switch between robotic and non-robotic procedures in the same space. Surgeons benefit from flexible port placement, choosing the setup that best fits their patient and their technique.

Versatile

Through design and technology, Versius Plus delivers the precision and efficiency surgeons' demand. Its integrated fluorescence visualisation system, vLimeLite, enables real-time ICG imaging, delivering multiple visualization modes with overlay and grayscale options. With a full surgical toolkit, Versius Plus is ready to transform surgical experiences in the OR.

Digitally-Driven

The Versius Plus ecosystem puts data at the user's fingertips with Versius Connect: A dedicated surgeon app with a near-real-time logbook of procedures and Versius Team: A live dashboard for surgical teams and hospitals, tracking usage, case volume, and system efficiency to help optimize robotics programs.

To learn more about CMR Surgical and its Versius Plus system, please visit .

Enquiries

About CMR Surgical Limited

CMR Surgical (CMR) is a global medical devices company dedicated to transforming surgery with Versius Plus, a next-generation surgical robot.

Headquartered in Cambridge, United Kingdom, CMR is committed to working with surgeons, surgical teams and hospital partners, to provide an optimal tool to make robotic minimal access surgery universally accessible and affordable. With Versius Plus, CMR Surgical is on a mission to redefine the surgical robotics market with practical, innovative technology and data that can improve surgical care. Founded in 2014, CMR Surgical is a private limited company backed by an international shareholder base.

The Versius Plus Surgical Robotic System

Versius Plus is a next-generation, portable surgical robot designed to help surgeons perform minimal access surgery (MAS). The Versius Plus Surgical System is a robotically assisted surgical device that is intended to assist in the precise and accurate control of Versius Plus Surgical endoscopic instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, electrosurgery, and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing.

In the U.S. the Versius Plus Surgical System is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy. Clinical indications vary by geography.

Versius Plus resets expectations of robotic surgery. Versius Plus fits into virtually any operating room set-up and integrates seamlessly into existing workflows, increasing the likelihood of robotic MAS. The compact, portable and modular design of Versius Plus allows the surgeon to only use the minimum number of arms needed for a given procedure.

Biomimicking the human arm, Versius Plus gives surgeons the choice of optimized port placement alongside the dexterity and accuracy of small fully wristed instruments. With 3D HD vision, easy-to-adopt instrument control and a choice of ergonomic working positions, the open surgeon console has the potential to reduce stress and fatigue while allowing for clear communication with the surgical team. By thinking endoscopically and operating robotically with Versius Plus, patients, surgeons and healthcare professionals can all benefit from the value that robotic MAS brings.

But it's more than just a robot. Versius Plus captures meaningful data with its wider digital ecosystem to support a surgeon's continuous learning. Through the Versius Plus Connect app, Versius Plus Trainer and CMR clinical registry, Versius Plus unleashes a wealth of insights to ultimately improve surgical care. For more information on Versius Plus, please visit:

Disclaimer:

Versius Plus is 510k cleared by FDA and is approved for sale in the United States.

Versius Plus is part of a Versius ecosystem comprised of the Versius Surgical System, the EIZO CuratOR product, the vLimeLite visualisation system, and a suite of electrosurgical and nonelectrosurgical instruments in the United States

CMR Surgical, the CMR Surgical logo, vLimeLite and Versius are trademarks or registered trademarks of CMR Surgical in the UK and other jurisdictions. EIZO, the EIZO logo, and CuratOR are trademarks or registered trademarks of EIZO Corporation in Japan and other countries Indocyanine green (ICG) is a drug and is not provided by CMR Surgical and must be independently sourced by the customer. The approval status of the drug may vary by country.

The Versius System vLimeLite Instructions for Use, including the approved indications, contraindications and warnings can be found in the product labelling supplied with each Versius Plus System. The Ultrasonic Dissector is not approved for sale in the United States. Versius and its associated products are commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. Please contact your local CMR Surgical representative for product availability in your region. Refer to the product-specific user manual for indications, contraindications, warnings, and other product information. The information is correct at the time of publication of this press release.

Safety Information

The Versius Plus Surgical System is a robotically assisted surgical device that is intended to assist in the precise and accurate control of Versius Plus Surgical endoscopic instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, electrosurgery, and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing.

The Versius Plus Surgical System is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy.

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