CMR Surgical, based in Cambridge, has achieved a groundbreaking milestone with the FDA approval for its Versius robotic system, marking a significant entry into the U.S. healthcare market.
- The Versius system enables enhanced precision in surgeries by mirroring human arm movements and is now approved for gallbladder procedures for adults.
- Having already completed over 26,000 surgeries worldwide, Versius stands as the second-most widely used robotic surgical system.
- The company has garnered substantial financial backing and employs over 500 staff, predominantly located in the UK.
- Future expansion plans include seeking regulatory approval in Japan and China, with potential consideration for an IPO.
CMR Surgical, a Cambridge-based company, has reached a significant milestone with the FDA’s approval for its Versius robotic system. This approval facilitates entry into the U.S. healthcare market, allowing the system to be used for gallbladder surgeries in adult patients aged 22 and above. The Versius system, engineered to emulate human arm movements, aims to boost surgeon precision and efficiency.
Already the second-most utilized robotic surgical system globally, the Versius has been deployed in over 26,000 surgeries. Its success marks a nearly decade-long journey since CMR Surgical’s inception in 2014. The company, headquartered and manufactured in Cambridge, is supported by international investors including SoftBank and Tencent.
Since its founding, CMR Surgical has raised about $1 billion and currently employs over 500 people, with 400 staff members based in the UK. Notably, a $600 million funding round in 2021 led by SoftBank was recorded as the largest private investment in the global medtech sector at that time.
Mark Slack, CMR’s chief medical officer and co-founder, articulated the significance of this accomplishment: “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.”
Beyond the U.S., CMR Surgical is aiming for regulatory acceptance in other major markets such as Japan and China. Although the company has contemplated an initial public offering, no definitive plans have been established, leaving it as a future possibility. As CMR continues expanding into key international markets, the Versius system solidifies its role as a formidable player in the expanding field of medical robotics.
CMR Surgical’s FDA approval for the Versius robotic system not only marks a pivotal milestone for the company but also heralds a new chapter for advancements in medical technology globally.
