The $3B Startup That Wants to Dethrone Robotic Surgery's King

Versius Plus also comes with integrated real-time fluorescence imaging (a technology that uses near-infrared light to help surgeons see blood flow and tissue structures) and digital tools for tracking efficiency. The Versius Connect app lets surgical teams log procedures and review performance data, essentially turning each operation into a learning opportunity.

The Clearance Story

The Versius Plus received FDA 510(k) clearance in December 2025 for cholecystectomy, which is the medical term for gallbladder removal, in adults aged 22 and older. That follows an earlier FDA authorization for the original Versius system in October 2024.

One approved procedure might sound limited, and it is. Intuitive's da Vinci platform is cleared for a wide range of surgeries across multiple specialties. But CMR is playing the long game. Globally, Versius has already been used in over 45,000 procedures across colorectal, urologic, gynecologic, thoracic, and general surgery. The company plans to pursue additional U.S. indications through partnerships with hospitals and ambulatory surgery centers.

CEO Massimiliano Colella called the U.S. launch a "watershed moment" for the company. Chris O'Hara, CMR's U.S. President and General Manager, emphasized plans to partner with "forward-thinking health systems" as the company builds its American footprint.

David's Slingshot: Portability and Price

CMR isn't going to outspend Intuitive. That's not the play. Instead, they're betting that hospitals are tired of the da Vinci model's rigidity.

Consider the economics of how Intuitive makes money. Roughly 81% of the company's income comes from services and accessory sales, not the robots themselves. It's the razor-and-blade model: sell the handle cheap, make a killing on cartridges. Once a hospital trains its surgeons on da Vinci, buys the instruments, and builds workflows around the system, switching costs become enormous. That ecosystem lock-in is Intuitive's deepest moat.

Versius's portability could be the crack in that wall. A single modular system serving multiple ORs means higher utilization rates and, theoretically, better return on investment. Smaller hospitals and ambulatory surgery centers that couldn't justify dedicating an entire operating room to a robot might find Versius a more practical option. CMR hasn't disclosed specific pricing, but the company has consistently emphasized "economic advantages" through its flexible deployment model.

Notably, CMR reportedly delayed its U.S. launch by a year to refine the Versius Plus platform, choosing to get the product right rather than rush into battle unprepared.

The Competition Is Getting Crowded

CMR isn't the only challenger circling Intuitive. Medtronic's Hugo system recently received FDA approval and has started performing surgeries in the U.S. Johnson & Johnson is developing its Ottava platform, targeting modularity and cost-efficiency. The surgical robotics market, projected to reach anywhere from $27 billion to $50 billion by the early-to-mid 2030s depending on the estimate, is attracting serious players who smell opportunity.

Intuitive isn't sitting still, either. The company installed 532 new systems in Q4 2025 alone and saw global procedure volumes grow approximately 18% year-over-year. Management expects procedure growth of 13% to 15% in 2026, a slight deceleration but still impressive for a company of its size.

So Can CMR Actually Win?

Let's be honest: unseating Intuitive Surgical is one of the hardest jobs in all of medtech. The installed base is massive, the surgeon training ecosystem is deep, and the recurring revenue model makes customers sticky. It's like trying to convince an entire city to switch from iPhones to Android when every app, accessory, and habit is built around Apple.

But CMR doesn't need to "win" in the traditional sense. They don't need to topple Intuitive; they need to capture the margins. Every hospital that couldn't previously afford robotic surgery, every ambulatory center looking for flexibility, every health system frustrated by OR scheduling bottlenecks around a single fixed robot: that's CMR's addressable market.

With over $1.3 billion raised (including a $200 million+ round in April 2025 specifically earmarked for U.S. commercialization), backing from heavyweights like SoftBank Vision Fund 2, GE Healthcare, and Lightrock, and a product that's already the second most widely used robotic platform globally, CMR has more than a prayer.

The real question isn't whether CMR can compete. It's whether the U.S. healthcare system, famously resistant to change, will give the new robot a fair shot. The next 18 months will tell us everything.

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