CMR Surgical Takes Its Versius Plus Robot Into the US Market and Files to Expand From Gallbladders Into Gynecology
After a December 510(k) clearance for cholecystectomy, the UK firm is commercializing Versius Plus in the US and has applied to add benign gynecology procedures.
Overview
CMR Surgical, the Cambridge, U.K. robotics firm, is moving its next-generation Versius Plus surgical robot into the United States and is already working to broaden the range of procedures the system is cleared to perform. The platform received 510(k) clearance from the U.S. Food and Drug Administration for cholecystectomy, or gallbladder removal, procedures, according to The Robot Report. On April 29, 2026, the company submitted a separate 510(k) application seeking to add benign gynecology procedures, according to a CMR Surgical press release distributed via GlobeNewswire.
The moves position CMR to compete in what its chief executive calls the world’s largest surgical robotics market, a market long dominated by Intuitive Surgical’s da Vinci system.
What We Know
The FDA granted the Versius Plus 510(k) clearance on December 17, 2025, for gallbladder removal procedures, according to MedTech Dive and Medical Device Network. The clearance builds on the FDA’s earlier authorization of CMR’s first-generation Versius system, which received marketing authorization through the de novo process in October 2024, according to The Robot Report.
With the clearance in hand, CMR said it is on track to begin commercialization in 2026, The Robot Report reported. The company raised more than $200 million in equity and debt investment in April to accelerate that US rollout, according to Medical Device Network.
Versius Plus is a modular, cart-based laparoscopic system. Medical Device Network reported that its modular design enables movement between hospital departments and integration into existing surgical workflows. The gynecology application describes an adaptable system with familiar laparoscopic port placement and fully wristed instrumentation compatible with 5mm ports, according to the CMR press release.
Outside the United States, CMR’s robotic platform has already completed more than 40,000 surgical procedures, according to The Robot Report. CMR describes its soft-tissue platforms as the second most used systems in the world after Intuitive Surgical, according to MedTech Dive. Versius Plus is already available in the UK and Europe, Medical Device Network reported.
The Gynecology Filing
The April 29 submission seeks clearance for benign gynecology procedures including total hysterectomy, oophorectomy, salpingectomy, and other gynecologic procedures, according to the CMR press release. The same release notes that the system is currently cleared in the US for cholecystectomy in adult patients 22 years of age and older, and describes Versius as the second most utilized surgical robotic system globally outside of the United States, with over 45,000 patients treated using the platform.
Massimiliano Colella, CMR’s chief executive officer, framed the gynecology push as central to the company’s US ambitions. “It is an exciting time for CMR as we seek to expand into gynecology in the U.S. and accelerate access to robotic-assisted surgery with Versius Plus in the largest surgical robotic market in the world,” he said, according to the CMR press release.
On the initial clearance, Colella said: “This 510(k) clearance represents an exciting new chapter for CMR Surgical as we introduce Versius Plus to the U.S. market,” according to The Robot Report. Chris O’Hara, CMR’s president and general manager of U.S. operations, described the system as built for hospital realities: “Versius Plus is designed to meet the practical realities of today’s healthcare environment — adaptable to different settings, efficient to integrate, and scalable for long-term growth,” he told Medical Device Network.
What We Don’t Know
Neither the timing nor the outcome of the gynecology 510(k) review has been disclosed; the application was pending as of the April announcement, according to the CMR press release. The company has not publicly detailed how many US hospitals or ambulatory surgical centers have agreed to install the system, or a per-unit price.
Analysis
The US market is the principal prize for surgical-robotics makers and the hardest to enter, given Intuitive Surgical’s entrenched da Vinci installed base. The global robotic surgical systems market is projected to reach $9.2 billion by 2034, up from $2.9 billion in 2024, according to Medical Device Network. CMR’s strategy of clearing one indication at a time — starting with high-volume, lower-acuity cholecystectomy and then pursuing gynecology, another large category of laparoscopic cases — is a measured path to building a US procedure base. The $200 million raised in April, per Medical Device Network, gives the company runway to fund installations and field support as that base grows.