CMR Surgical Gains FDA Approval to Market Versius System in the U.S.

CMR Surgical has achieved a significant milestone by securing U.S. Food and Drug Administration (FDA) marketing authorization for its Versius robotic surgical system, marking its entry into the world’s largest healthcare market. This approval allows the company to prepare for the sale of the Versius system in the U.S., initially targeting gallbladder removal surgeries for adult patients aged 22 and older.

The Versius system is engineered to replicate the movements of the human arm, enhancing surgical precision. It is already the second-most widely used robotic surgical system worldwide, with over 26,000 surgeries completed globally, including many in the UK. The approval comes nearly a decade after CMR Surgical was founded in 2014 and represents a significant step in the company’s growth trajectory.

Headquartered in Cambridge, CMR Surgical boasts a manufacturing site that is supported by international investors, including Japanese tech giant SoftBank and Chinese conglomerate Tencent. Since its inception, the company has raised approximately $1 billion and currently employs over 500 staff, with around 400 of those based in the UK. Notably, a $600 million funding round led by SoftBank in 2021 marked the largest private investment in the global medtech sector to date.

Mark Slack, CMR’s chief medical officer and co-founder, expressed the importance of this FDA approval. “Securing FDA marketing authorization 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,” he stated.

In addition to the U.S. market, CMR Surgical is actively pursuing regulatory approvals in other major healthcare markets, including Japan and China. The company’s global expansion strategy underscores its commitment to advancing the accessibility and efficiency of robotic-assisted surgery.

While CMR Surgical has previously contemplated an initial public offering (IPO), no formal plans have been announced as of now. However, an IPO remains a possibility as the company continues to expand into key international markets.

Founded in 2014, CMR Surgical has rapidly established itself as a competitor in the growing field of medical robotics. The recent FDA approval is set to bolster its presence on the global stage, paving the way for wider adoption of the Versius system and further innovations in robotic-assisted surgery. As the company looks ahead, it aims to enhance surgical outcomes and accessibility for patients worldwide.