CMR Surgical, a Cambridge-based medical technology company, has made significant progress after receiving marketing authorization from the US Food and Drug Administration (FDA) for its Versius Surgical portable system.
This represents an important step in the world’s largest healthcare market, enabling CMR to prepare for sales of the Versius system in the United States, initially for gallbladder removals in adult patients aged 22 years and older.
Designed to mimic human arm movements and enhance a surgeon’s precision, the Versius system is the second most widely used robotic surgical system globally, with more than 26,000 surgeries completed, including in the UK. This approval comes nearly a decade after CMR Surgical was founded in 2014.
CMR Surgical’s headquarters and manufacturing site remain in Cambridge, with support from international investors, including Japanese technology giant SoftBank and Chinese company Tencent. The company, which has raised nearly $1 billion since its inception, employs more than 500 people, 400 of whom are based in the UK. The company’s $600 million funding round in 2021, led by SoftBank, represents the largest private investment ever in the global medical technology sector.
Mark Slack, chief medical officer and co-founder of CMR, highlighted the importance of approval: “Receiving marketing authorization from the FDA for Versius is a major milestone for CMR and, more importantly, for hospitals and patients who will now have greater access to Robots. Assisted surgery.”
Outside the United States, CMR Surgical is also seeking regulatory approval in other major healthcare markets, including Japan and China.
Although the company has previously considered an initial public offering (IPO), no formal plans have been announced. An IPO remains an option for the future as CMR continues its expansion into key international markets.
Founded in 2014, CMR Surgical has grown rapidly, enhancing the accessibility and efficiency of robotic-assisted surgery globally. Its Versius system now stands as a major contender in the booming market for medical robotics, with the recent US Food and Drug Administration (FDA) approval to strengthen its presence on the global stage.