CMR Surgical Ltd. hopes to soon gain U.S. FDA 510(k) clearance for its Versius Plus surgical robotic system to bring it to the U.S. market amid rising demand for robotic surgery. Although the company’s original Versius system received FDA clearance in 2024 for use in cholecystectomy in adults, CMR waited to bring the enhanced Versius Plus model to market instead. “I have such a respect for the U.S. market that the last thing that I would do is to enter a market with a product that is outdated,” Massimiliano Colella, CMR CEO told BioWorld.

CMR Surgical Ltd. secured more than $200 million in funding to bring its surgical robotic system, Versius, to the U.S. market and expand elsewhere. The financing, which came in the form of equity and debt, is “highly important” for the company and comes at the right time as it is “expanding and growing nicely,” company CEO Massimiliano Colella told BioWorld.

The U.S. FDA granted Momentis Surgical Ltd. 510(k) clearance for its Anovo robotic surgical platform for use in single site, abdominal access ventral hernia repairs. The U.S. regulatory agency also gave the greenlight to CMR Surgical Ltd.’s Versius system for use in cholecystectomy, in a sign of the growing market for smaller, more portable robotic devices to assist in minimally invasive procedures.

CMR Surgical Ltd. recently submitted its application to the U.S. FDA for approval for its Versius surgical system as it seeks to get more surgeons using the small, portable, robotic tool in laparoscopic procedures.

CMR Surgical Ltd. raised $165 million in financing from its existing investors that will allow the company to continue to innovate its portable robotic surgery system, Versius, and grow its position in existing and new markets. The latest financing takes CMR’s total capital raised since its founding to over $1 billion. The Versius surgical robotic system is now in over 20 markets and the company has become the second largest soft tissue surgical robotics company globally, after Intuitive Surgical Inc.

LONDON – CMR Surgical Ltd. has once again broken the record for a private financing round by a European med-tech company, raising $600 million in a series D funding round. That follows on from two other record-breaking rounds, in which the Cambridge, U.K.-based CMR raised $240 million in a series C in September 2019 and $100 million in the series B round that closed in May 2018. These earlier rounds enabled CMR to complete development and install the first commercial versions of its Versius surgical robots. Now the series D will push the company through to profitability, the company said.