The U.S. regulatory authorities have granted approval for a portable surgical robot created by a company based in Cambridge.

In a significant advancement for CMR Surgical within the expansive U.S. healthcare sector, the firm announced that the Food and Drug Administration (FDA) has approved marketing for its Versius Surgical System.

This approval comes a decade after the company’s inception, allowing CMR Surgical to move forward with plans to market Versius in the United States for gallbladder removal procedures in adult patients aged 22 and older.

Engineered to replicate the functionality of the human arm and assist surgeons during operations, Versius is already the second-most popular surgical robotic system globally, having been used in 26,000 surgeries, including those performed in the UK.

Founded in 2014 and still headquartered in Cambridge, CMR Surgical also operates a manufacturing facility in the same area. The company enjoys financial backing from prominent global investors, including SoftBank.

With a workforce exceeding 500 employees—around 400 of whom are in the UK—CMR Surgical has successfully secured roughly $1 billion in funding since its establishment. Notably, a $600 million funding round led by SoftBank in 2021 was the largest recorded in global medtech private funding.

Other notable investors consist of Tencent, a major Chinese technology company, and Cambridge Innovation Capital, which collaborates with Cambridge University and local innovation hubs to bring intellectual property to market.

Mark Slack, the chief medical officer and co-founder of CMR Surgical, remarked: “Obtaining FDA marketing approval for Versius represents a vital achievement for CMR and is crucial for hospitals and patients, providing expanded access to robotic-assisted surgery.”

CMR Surgical is also actively seeking marketing approvals in Japan and China, two other significant healthcare markets.

Martin Frost, another co-founder and former CEO, mentioned in 2018 during a funding round that aimed for regulatory approval in the U.S. by 2019 and hinted at the potential for an initial public offering (IPO) in the future.

Although the IPO possibility still exists, no formal process has yet been initiated.