CMR Surgical has achieved a critical milestone with FDA approval for its innovative Versius robotic system.
- This approval enables CMR Surgical to enter the US market, initially targeting gallbladder surgeries for adults aged 22 and above.
- The Cambridge-based company has already seen substantial success internationally, with over 26,000 procedures completed using the Versius system.
- Backed by prominent investors from SoftBank and Tencent, CMR Surgical has raised nearly $1 billion to date.
- CMR is also pursuing regulatory approval in other significant markets including Japan and China.
CMR Surgical, based in Cambridge, has received FDA approval for its pioneering Versius robotic system, marking a significant step forward in accessing the world’s largest healthcare market. This approval allows CMR Surgical to commence sales in the US, initially focusing on gallbladder surgeries for adult patients aged 22 and older.
The Versius system is designed to mimic the movements of the human arm, enhancing precision and control for surgeons during procedures. Globally, it is the second most widely adopted robotic surgical system, with a record of over 26,000 surgeries already performed, including in the UK.
Formed nearly a decade ago in 2014, CMR Surgical has grown rapidly, supported by significant backing from international investors, most notably from Japanese tech giant SoftBank and China’s Tencent. With its headquarters and manufacturing base strategically located in Cambridge, the company employs more than 500 people, with 400 staff based in the UK.
In 2021, CMR Surgical secured a substantial $600 million in funding, the largest private investment in the medtech sector globally, led by SoftBank. This financial injection has been pivotal in propelling the company’s innovations and market reach.
CMR’s Chief Medical Officer and co-founder, Mark Slack, emphasised the importance of the FDA approval, stating, “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.” As the company seeks further expansion, it is actively pursuing regulatory approvals in other major healthcare sectors, such as Japan and China.
The FDA approval marks a crucial advancement for CMR Surgical, enhancing its global presence and accessibility of robotic-assisted surgeries.
