CMR Surgical announced that its second-gen Versius Plus surgical robotic system has received U.S. Food and Drug Administration (FDA) 510(k) clearance for cholecystectomy procedures.

Versius Plus features a flexible, modular design and a data-driven ecosystem. The company said it’s designed not just for the surgeon, but the whole OR team—its open console facilitates communications between the surgeon and other medical professionals.

CMR’s first-gen Versius surgical system was approved through the De Novo process in October 2024. Now that Versius Plus is 510(k)-cleared, the company plans to begin its 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,” said CMR Surgical CEO Massimiliano Colella. “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.”

Versius Plus does not require a dedicated OR, so hospitals can switch between robotic and non-robotic procedures in the same space. Its flexible port placement allows surgeons to choose the setup that best first their patient and technique. An integrated fluorescence visualization system, vLimeLite, allows real-time ICG imaging with multiple visualization modes with overlay and grayscale options.

Its dedicated Versius Connect surgeon app has a near-real-time logbook of procedures. The Versius Team live dashboard tracks usage, case volume, and system efficiency to help optimize robotics 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, CMR Surgical’s U.S. president and GM. “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.”

In October, the company revealed that it’s an early adopter of NVIDIA IGXThor as it assesses its integration into the Versius surgical system. IGX Thor is NVIDIA’s latest, most powerful platform for physical artificial intelligence (AI) and robotics.