UNIT-9085EST.2025 · IDX.300
MedicalIn production

Versius Plus

CMR Surgical · United Kingdom · 2025

The second-generation Versius: same wheelable arms, now with fluorescence imaging and CMR's first energy instrument — and the machine that finally opened the US market.

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Versius Plus keeps everything that made the original odd — separate bedside units wheeled in one at a time, a biomimetic shoulder-elbow-wrist arm, 5 mm fully wristed instruments, no dedicated robotic operating room — and fixes what kept it out of the top tier of the operating theatre. The headline addition is vLimeLite, near-infrared fluorescence imaging that lights up perfusion and biliary anatomy through injected indocyanine green; until now CMR had nothing to answer Intuitive's Firefly with. Second is the ultrasonic dissector, CMR's first advanced-energy instrument, which removes the awkward workflow of swapping to handheld energy devices mid-case. The rest is visualisation and data: a larger, brighter console display with automatic brightness and stronger Vision control, a 3D HD feed so the bedside team sees what the surgeon sees, and a link into CMR's digital platform. The regulatory story is the more interesting one. The first-generation Versius took the slow route — a De Novo petition filed in November 2023 that took eleven months and created an entirely new FDA device class in October 2024. Versius Plus then rode that precedent as a plain 510(k): filed 17 November 2025, cleared 16 December 2025, twenty-nine days. The indication is still narrow — cholecystectomy in adults aged 22 and over — and CMR has filed to widen it, submitting a gynaecology 510(k) on 29 April 2026 that remains pending. Commercial launch in the US began in 2026, announced at SAGES in Tampa on 26 March 2026 alongside a global milestone of 45,000 patients treated on the Versius platform across more than 30 countries. In Europe the family went the other way in January 2026, when Versius picked up a CE mark for paediatric surgery — making CMR one of only three surgical-robotics companies with a European paediatric indication.

#surgical#portable#modular#fluorescence-imaging#fda-cleared
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