The United States represents a significant market with a strong demand for a flexible surgical robotic system applicable across various care settings. However, there has been a lack of sufficient options in the surgical field for robotic systems in the United States. Out of nearly 10 million major operating room procedures performed annually in the country, only about 2.5% were assisted by robotic technology. This highlights a pressing need for more compact, modular systems that can be utilized in different environments. A new compact, modular, and portable surgical robotic system could now enable hospitals of any size in the United States to offer robotic-assisted surgery.

CMR Surgical (Cambridge, UK) has received marketing authorization from the U.S. Food and Drug Administration (FDA) for the Versius Surgical System, which paves the way for the introduction of a next-generation versatile, adaptable, and digitally driven surgical robot in the United States. Versius is the first multi-port, soft tissue general surgical Robotic Assisted Surgical Device (RASD) to be successfully authorized through the FDA’s De Novo application process. Versius is designed to assist in the precise and accurate control of Versius Surgical endoscopic instruments and is indicated for use in the United States with adult patients aged 22 and older who qualify for soft tissue minimal access surgery, specifically for cholecystectomy. Globally, Versius is the second most widely used surgical robotic system, with over 26,000 surgical procedures performed across Europe, Latin America, Asia, the Middle East, and Africa.

Versius is compact and modular, allowing it to serve as a versatile and portable surgical robot that can seamlessly integrate into nearly any operating room to conduct cholecystectomy procedures. Its design facilitates easy movement between departments, making it adaptable for various care settings. Versius mimics the human arm, enabling surgeons to achieve optimal port placement with the dexterity and precision of small, fully wristed instruments. The system offers 3D HD vision, user-friendly instrument control, and various ergonomic working positions, with an open surgeon console that may help reduce stress and fatigue while promoting clear communication among the surgical team. As a digitally driven system, Versius is committed to continuous innovation through software updates, ensuring that customers have access to the latest technology advancements. With a suite of digital applications to support surgeons, surgical teams, and hospitals, Versius delivers real-time insights to enhance proficiency and optimize surgical robotic programs.

“Securing FDA marketing authorization for Versius for use in cholecystectomy in adult patients is a significant milestone for CMR and, most importantly, for hospitals and patients who will now have greater access to robotic-assisted surgery in cholecystectomy procedures,” said Mark Slack, Chief Medical Officer and Co-founder at CMR Surgical. “With FDA authorization, we can now bring our compact and portable surgical robot to the world’s largest healthcare market, expanding the benefits of robotic-assisted surgery with Versius across various care settings in the U.S.” 

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