CMR Surgical said its second-generation surgical robotic platform, Versius Plus, has received 510(k) clearance from the FDA for cholecystectomy procedures.
The company said the Versius Plus' open console facilitates communication between the surgeon and other medical professionals, which supports real-time decision making.
The FDA previously granted marketing authorization for CMR’s first-generation Versius Surgical System through the De Novo process in October 2024. With the 510(k) clearance of Versius Plus, CMR is on track to begin commercialization in 2026.
Outside of the United States, CMR’s robotic surgical platforms have already completed more than 40,000 surgical procedures, which it said makes the soft tissue robotic platforms the second most used globally.
“This clearance represents an exciting new chapter for CMR Surgical as we introduce Versius Plus to the U.S. market. Built on years of global clinical use data, Versius Plus delivers the flexibility and intelligence today’s healthcare institutions need to advance robotic-assisted surgery. It’s inspiring to see our new technology transforming the landscape of surgical care," said CMR Surgical CEO Massimiliano Colella in a statement.
