CMR Surgical receives FDA clearance for Versius Plus surgical robot

CMR Surgical this week said its second-generation surgical robotic platform, Versius Plus, has received 510(k) clearance from the U.S. Food and Drug Administration for cholecystectomy, or gallbladder removal, procedures.

“This 510(k) clearance represents an exciting new chapter for CMR Surgical as we introduce Versius Plus to the U.S. market,” said Massimiliano Colella, CEO at CMR Surgical. “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.”

Founded in 2014, CMR has worked with surgeons, surgical teams, and hospital partners to develop a tool to make minimal access surgery (MAS) more accessible and affordable. Versius has a compact, portable, and modular design to fit into virtually any operating room, according to the Cambridge, U.K.-based company.

In April, CMR raised $200 million in funding to expand access to its Verisus robot.

Versius is designed for flexibility

Versius Plus offers a modular design and is backed by a data-driven digital ecosystem. CMR said it provides more flexibility for surgeons and hospitals. The system features an open console that facilitates communication between the surgeon and other medical professionals, which supports real-time decision-making.

With Versius Plus, CMR said hospitals can easily switch between robotic and non-robotic procedures in the same space. Surgeons can also benefit from flexible port placement, choosing the setup that best fits their patient and their technique.

The system also features an integrated fluorescence visualisation system, vLimeLite. This enables real-time ICG (Indocyanine Green) 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,” the company said.

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, the company said it is on track to begin commercialization in 2026.

CMR Surgical works on more indications in the U.S.

Outside of the U.S., CMR’s robotic platform has already completed more than 40,000 surgical procedures. The company has worked to establish a strong foundation for its performance across multiple specialties and care settings.

“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 and general manager of U.S. operations at CMR Surgical.

“FDA clearance represents an exciting opportunity to partner with healthcare systems across the U.S.,” he said. “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.”

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. It also includes Versius Team, a live dashboard for surgical teams and hospitals, tracking usage, case volume, and system efficiency to help optimize robotics programs.