CMR Surgical Receives Breakthrough Clearance for Versius Plus Robotic System

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

Versius Plus features a flexible, modular design and a data-driven digital ecosystem, providing greater choice for surgeons and hospitals. 

The system is designed for the entire operating room team, with an open console that supports communication and real-time decision-making during surgery.

The company’s first-generation Versius Surgical System received marketing authorisation through the De Novo process in October 2024. 

With FDA clearance for Versius Plus, CMR plans to begin commercialisation in the U.S. in 2026. Outside the U.S., CMR’s robotic platforms have completed over 40,000 procedures, making the soft tissue robotic systems the second most widely used globally.

Versius Plus offers a compact, modular design that allows hospitals to move the system between departments and operating rooms without a dedicated OR. 

Surgeons benefit from flexible port placement, while integrated fluorescence visualisation enables real-time imaging in multiple modes.

The system’s digital ecosystem includes Versius Connect, an app providing near-real-time surgical logs, and Versius Team, a dashboard tracking usage, case volume, and efficiency.

This data-driven approach supports optimisation of robotic-assisted surgical programmes, offering adaptable, versatile, and digitally-enhanced solutions for modern operating rooms.