CMR Surgical announces an NVIDIA simulation workflow for Versius Plus - 2026-07-22 - Demonstration - The workflow uses NVIDIA Isaac for Healthcare’s Medical Physics Simulation framework and Cosmos-H-Dreams. CMR planned to showcase the simulation at the Society of Robotic Surgery conference in Florida on July 23–26, 2026. The… - source: us.cmrsurgical.com
FDA records an open Class II recall for two Versius surgeon consoles - 2026-07-09 - Regulatory - The recall covers two V-SS-1020 consoles running Pratchett 1 version 62.1 that were distributed in California. The firm initiated the recall on June 9, 2026 and the corrective action is to notify customers and configure secure boot… - source: accessdata.fda.gov
CMR Surgical submits Versius Plus 510(k) for benign gynecology - 2026-04-29 - Regulatory - The submission seeks clearance for benign procedures including total hysterectomy, oophorectomy and salpingectomy. CMR said the filing builds on global clinical experience and supports its U.S. market expansion. This is a premarket… - source: us.cmrsurgical.com
FDA clears Versius Plus for adult cholecystectomy - 2025-12-16 - Regulatory - 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… - source: us.cmrsurgical.com