CMR Surgical Wins FDA Clearance for Versius Plus, Opening Door to U.S. Robotic Surgery Market

CMR Surgical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation robotic surgery system, Versius Plus, marking a major step toward entering the highly competitive U.S. surgical robotics market.

The clearance allows Versius Plus to be used for gallbladder removal (cholecystectomy) procedures and paves the way for a commercial launch in the U.S. planned for 2026. For CMR Surgical, the decision represents a long-awaited milestone as the company expands beyond its strong presence in Europe and other international markets.

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A New Entrant in a Crowded Robotics Market

Versius Plus is the latest version of CMR's modular robotic platform, designed for soft-tissue surgeries such as general surgery, gynecology, and urology. While the U.S. market has long been dominated by Intuitive Surgical's da Vinci system, new competitors are increasingly challenging that position.

CMR says its robotic systems are already the second most widely used soft-tissue surgical robots globally, with more than 40,000 procedures performed outside the U.S. The FDA clearance now positions the company to compete directly in the world's largest market for robotic-assisted surgery.

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Designed Around Surgeon Workflow

One of Versius Plus's defining features is its modular, mobile design, which allows hospitals to move the system between operating rooms instead of dedicating a single space to robotics. This flexibility is particularly attractive for hospitals seeking to expand robotic surgery without major infrastructure changes.

The system also features an open surgeon console, enabling better communication between surgeons and operating room staff during procedures. CMR says this design supports teamwork and situational awareness compared to closed-console systems.

Versius Plus integrates digital tools such as Versius Connect, which helps hospitals track procedure volumes, system usage, and performance data. These capabilities are increasingly important as providers look to improve efficiency and measure outcomes in robotic surgery programs.

Backed by Strong Funding and Momentum

The FDA decision follows a period of strong financial backing for CMR Surgical. Earlier this year, the company raised over $200 million to support its U.S. expansion and commercialization efforts.

CEO Massimiliano Colella described the clearance as a "significant milestone," adding that it reflects the company's goal of making robotic surgery more accessible to hospitals and surgical teams worldwide.

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Competition Continues to Intensify

CMR's U.S. entry comes as competition in surgical robotics accelerates. Recently, Medtronic received FDA clearance for its Hugo robotic system for urologic procedures, while SS Innovations has submitted its SSi Mantra system for regulatory review.

With hospitals increasingly adopting robotic platforms for minimally invasive surgery, the FDA clearance of Versius Plus highlights how quickly the surgical robotics market is expanding, and how global players are positioning themselves for growth in the U.S.

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