CMR Surgical gains FDA clearance for new robot

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.”

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