CMR Surgical Kicks Off US Launch of Versius Plus, Opening a Second Front Against Intuitive Surgical's Da Vinci
After FDA 510(k) clearance in December and a 45,000-patient global milestone in March, the Cambridge-based surgical robotics company begins placing its modular, lower-cost Versius Plus system in US hospitals.
Overview
CMR Surgical, the Cambridge, UK-based maker of the Versius robotic surgical platform, has begun the US commercial rollout of its second-generation Versius Plus system, the company said when it announced a 45,000-patient global milestone at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2026 Annual Meeting in Tampa. The launch follows the FDA’s December 2025 510(k) clearance of Versius Plus for cholecystectomy and marks the first serious soft-tissue challenge to Intuitive Surgical’s da Vinci on its home turf in more than a decade.
What We Know
The FDA granted 510(k) clearance to Versius Plus on December 16, 2025, with the agency’s authorization covering adult patients 22 years and older eligible for soft tissue minimal access surgery for cholecystectomy, according to CMR Surgical’s announcement. The clearance was issued through the predicate-based 510(k) pathway, building on the first-generation Versius system’s De Novo authorization granted in October 2024.
Versius Plus adds several capabilities to the original platform. The system integrates a fluorescence visualization module called vLimeLite, which uses indocyanine green imaging to highlight blood flow during procedures, per reporting from Fierce Biotech. CMR has also introduced its first advanced-energy instrument, an ultrasonic dissector, and a digital layer consisting of the Versius Connect surgeon logbook app and the Versius Team hospital dashboard. CEO Massimiliano Colella described the clearance as “an exciting new chapter for CMR,” and Chris O’Hara, the company’s US president and general manager, said Versius Plus “was designed to meet the practical realities of today’s healthcare environment.”
On March 26, 2026, at SAGES in Tampa, CMR announced that more than 45,000 patients have now been treated globally with Versius systems, across more than 30 countries. The same announcement formalized the company’s US commercial debut. Colella called the moment “a watershed” for CMR and said the company would focus on partnerships with both hospitals and ambulatory surgical centers. Internationally, Versius has been used for general surgery, colorectal, urologic, gynecologic and thoracic procedures, although the US indication is currently limited to gallbladder removals.
The US push is backed by substantial capital. In April 2025, CMR closed a financing round of more than $200 million in combined equity and debt, with new debt provided by Trinity Capital and Armentum Partners acting as financial advisor. The company earmarked the proceeds for global commercialization, with a specific emphasis on the US market and the Versius Plus launch.
Market Context
The US soft tissue robotic surgery market has long been a near-monopoly for Intuitive Surgical, whose da Vinci platform holds an estimated 86.5 percent share, according to Fierce Biotech’s analysis citing industry data. The broader global robotic surgery market is growing at roughly 12.1 percent annually and is projected to reach $9.2 billion by 2034, up from $2.9 billion in 2024, the same report noted.
CMR is not the only challenger arriving this cycle. Medtronic’s Hugo robotic system received its first US FDA clearance in late 2025 for a urologic indication, and Johnson & Johnson is preparing its own FDA submission for its Ottava system, Fierce Biotech reported. Unlike those competitors, CMR is entering with a platform that has already accumulated more than 40,000 procedures outside the US and, according to the company, is the second most widely used soft tissue surgical robot globally.
CMR’s differentiation pitch rests on the hardware’s form factor. Versius Plus is built around independent arm carts that can be wheeled between operating rooms and positioned around the patient, rather than the single large bedside unit that characterizes da Vinci installations. The company argues this avoids the need for a dedicated robotic OR and allows hospitals to switch between robotic and conventional laparoscopic procedures in the same space, as described in its 510(k) announcement.
What We Don’t Know
CMR has not disclosed the list price or per-procedure economics for Versius Plus in the US market, nor has it named the first US hospitals or surgery centers to receive systems. The current cholecystectomy-only indication is narrow compared with the platform’s international use, and the company has not published a timeline for filing the additional indications — urology, gynecology, colorectal, thoracic — that would be required to compete with da Vinci across its full footprint.
The company’s own corporate trajectory is also in question. Earlier reports in the medical-device trade press have suggested CMR is exploring strategic options, including a potential sale at a valuation of up to $4 billion, although CMR has not publicly confirmed any such process. How that backdrop affects pricing, sales-force investment, and the pace of additional regulatory filings is unclear.
Analysis
For two decades, surgeons looking for a soft tissue robot in a US hospital have had, in practical terms, one option. The da Vinci’s dominance has been reinforced by training pipelines, capital lock-in, and the absence of credible alternatives cleared for the same indications. Versius Plus does not end that dominance, and with a single cleared indication it cannot. But it is the first cart-based, modular soft tissue system from a company with a meaningful international install base to reach the US clearance bar, and it arrives alongside Medtronic’s Hugo and, soon, J&J’s Ottava.
The immediate question is not whether CMR can displace da Vinci but whether the US market can support a second, third, and fourth robotic platform at scale — and at what price points. A system that hospitals can share across operating rooms, rather than dedicating a single OR to robotics, is a distinct commercial proposition from Intuitive’s model, and ambulatory surgery centers, which handle high volumes of gallbladder cases, are an explicit target. How quickly CMR can convert its SAGES-era US debut into disclosed installations will be the next indicator of whether Versius Plus is a genuine second entrant or an international platform carefully parked at the edge of a market it cannot economically win.