UK-based CMR Surgical has secured FDA 510(k) clearance for Versius Plus, its second-generation modular surgical robotic system, the company announced as it readies a U.S. commercial launch.
What’s Cleared
The clearance covers cholecystectomy in adult patients 22 years and older. Versius Plus is a portable, modular soft-tissue robot designed to slip into existing operating rooms without a dedicated OR. It pairs flexible port placement and small wristed instruments with an open surgeon console and an integrated fluorescence visualisation system called vLimeLite.
Building On A Global Base
Outside the U.S., CMR’s platforms have already supported more than 40,000 surgical procedures, making them the second-most-used soft-tissue robotic systems globally. The first-generation Versius received FDA De Novo authorization in October 2024; Versius Plus extends that with a refreshed surgeon console, the Versius Connect surgeon app and a Versius Team live dashboard for hospitals.
What Executives Say
“Versius Plus delivers the flexibility and intelligence today’s healthcare institutions need to advance robotic-assisted surgery,” CMR CEO Massimiliano Colella said. U.S. GM Chris O’Hara called the clearance “an exciting opportunity to partner with healthcare systems across the U.S.”, with additional indications under development.
Competitive Backdrop
The clearance ratchets up pressure on Intuitive Surgical’s da Vinci franchise and broadens U.S. competition in soft-tissue robotics, alongside Medtronic’s Hugo and J&J’s OTTAVA. See our coverage of J&J’s positive OTTAVA pivotal data and the FDA’s recent clearance of Perimeter Medical’s Claire for related context.
Reporting based on coverage from CMR Surgical, MedTech Dive, and MedCity News.