British medical robotics company CMR Surgical has begun the U.S. commercial launch of its next-generation Versius Plus robotic surgical system, the company said this week, following the FDA 510(k) clearance granted in December 2025 for laparoscopic gallbladder removal. The launch ends a years-long wait for CMR to enter the United States, by far the largest market for robotic soft-tissue surgery.
From 45,000 patients abroad to American operating rooms
The original Versius platform has been used in more than 45,000 procedures across more than 30 countries, spanning colorectal, urologic, gynecologic, thoracic and general surgery. Versius Plus brings refreshed instruments, an upgraded vision system and a smaller cart-based footprint that CMR says is well-suited to ambulatory surgery centres, not just large academic hospitals.
An overdue rivalry for Intuitive
For more than two decades, Intuitive Surgical's da Vinci has had near-monopoly status in U.S. soft-tissue robotics. That is starting to change. Medtronic's Hugo system received FDA clearance in December 2025, Johnson & Johnson submitted its Ottava robot for FDA review in early 2026, and SS Innovations is awaiting a decision on Mantra. CMR's argument is that Versius Plus is the only U.S.-cleared platform built around modular, individually portable arms.
Going past the academic centres
CMR's commercial strategy looks different from earlier entrants. The company is targeting both hospitals and ambulatory surgical centres, and has signed early partnerships with U.S. health systems to bring Versius Plus into community surgery first, with cholecystectomy as the wedge procedure. Additional FDA submissions for new indications are already in the works, the company said.
Market reset
Analysts expect U.S. robotic soft-tissue procedure volume to grow well past 2 million cases by 2030. With CMR, Medtronic, J&J and SS Innovations all entering at once, hospitals will for the first time be able to negotiate across multiple platforms — a structural shift that could reset pricing and indication breadth for a market that has been single-vendor for a generation.
Reporting based on coverage from CMR Surgical, MassDevice, MedTech Dive and FierceBiotech.