CMR Surgical Gains FDA Clearance for Versius Plus, Eyes US Market Entry in 2026

CMR Surgical has obtained US Food and Drug Administration (FDA) clearance for its Versius Plus robotic surgical system, marking a key step toward launching commercial operations in the US in 2026. The approval builds on the FDA’s de novo classification of the company’s first-generation Versius system granted in October 2024.

Versius Plus is currently approved for gallbladder removal procedures and features a modular, mobile design that enables seamless movement across hospital departments and easy integration into existing surgical workflows. The system has been developed to align with the operational demands of modern healthcare settings, offering flexibility, efficiency, and scalability.

CMR plans to expand Versius Plus’s indications in the US to support a wider range of soft-tissue procedures. To support its commercial rollout, the company raised $200m in equity and debt financing in April. Already marketed in Europe and the UK, Versius systems have been used in more than 40,000 procedures worldwide.

01-01-2026