Dive Brief:
- CMR Surgical said Tuesday it received 510(k) clearance from the Food and Drug Administration for its next-generation robotic system to perform gallbladder removal procedures.
- The Cambridge, England-based company said more than 40,000 surgical procedures have been completed with its robotic platforms outside of the U.S., across multiple specialties and care settings.
- CMR said it is on track to begin launching the new system, called Versius Plus, in the U.S. in 2026.
Dive Insight:
CMR gained FDA marketing authorization for its first-generation Versius robot in October 2024 through the de novo pathway. In April, the company said it raised more than $200 million to support the commercialization of Versius.
The company claims its soft tissue platforms are the world’s second most used robotic systems, behind market leader Intuitive Surgical. In the U.S., CMR said it has received strong interest in its new robot from surgeons across the country.
“This clearance represents an exciting new chapter for CMR Surgical as we introduce Versius Plus to the U.S. market,” CEO Massimiliano Colella said in a statement. “It’s inspiring to see our new technology transforming the landscape of surgical care.”
Among its features, the robot is modular in design, so it can be moved between operating rooms, with an open console to support communication and decision making between the surgeon and clinical team. An integrated visualization system enables real-time imaging. A dedicated surgeon app called Versius Connect logs procedures, while a live dashboard for the surgical team and hospital tracks usage, case volume and system efficiency.
CMR said the advanced version of Versius can also support a range of soft tissue procedures, and the company will pursue additional indications for the robot in the U.S.
The introduction of Versius Plus comes as more robot makers gear up to challenge Intuitive in the U.S. soft tissue robotics market. Earlier this month, Medtronic won FDA clearance for its Hugo system, with an initial indication for urologic procedures. Also this month, SS Innovations submitted an application with the FDA seeking 510(k) clearance for its SSi Mantra surgical robotic system.
