FDA clears Versius Plus for adult cholecystectomy
CMR Surgical received FDA 510(k) clearance for Versius Plus to assist surgeons performing minimally invasive gallbladder removal in adults aged 22 and older.
Evidence notes
- The clearance covers robotically assisted cholecystectomy in adults aged 22 and older.
- Versius Plus remains surgeon-controlled and uses modular bedside arm units with an open console.
- CMR said U.S. commercialisation would begin in 2026.
Company context
CMR Surgical develops Versius, a modular and portable robotic system for minimal-access surgery. The Cambridge company combines independent bedside units, surgical instruments, vision and a digital ecosystem intended to help hospitals expand access to robot-assisted procedures.