Cambridge surgical robot approved by US regulators

A portable surgical robot developed by a Cambridge-based company has been approved by US regulators.
In a breakthrough for CMR Surgical in the world’s biggest healthcare market, the company said America’s Food and Drug Administration had granted marketing authorisation for its Versius Surgical System.
The green light, a decade after the company was founded, means CMR Surgical can now prepare to sell Versius in the US for use for adult patients 22 years old and above for gallbladder removal surgery.
Versius, designed to biomimic the human arm and assist surgeons, is already the world’s second-most utilised surgical robotic system, with 26,000 surgical cases completed, including in the UK.
CMR Surgical was founded in 2014 and remains based in Cambridge where it also has a manufacturing site. It is backed by international investors including SoftBank.
The company employs more than 500 people, including about 400 in the UK, and has raised about $1 billion since it was founded, including through a $600 million round in 2021 which was led by SoftBank, the Japanese investor, and was the largest global medtech private funding round.
Other investors include Tencent, the Chinese tech conglomerate, and Cambridge Innovation Capital, which partners with Cambridge University and surrounding clusters to commercialise intellectual property.
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Mark Slack, chief medical officer and co-founder at CMR Surgical, said: “Securing FDA marketing authorisation for Versius is a significant milestone for CMR and, most importantly, for hospitals and patients who will now have greater access to robotic-assisted surgery.”
The company is also pursuing marketing approval in Japan and China, other big healthcare markets.
Martin Frost, another co-founder and former chief executive, had said in 2018 at the time it raised $100 million that it was targeting regulatory approval in the US in 2019 and had raised the prospect of a future initial public offering.
An IPO is understood to remain an option but no process has been started.