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AdminJul 1, 2024< 1 min read

Intuitive Announces FDA Clearance of Revised da Vinci Xi and X Labeling on Radical Prostatectomy

Intuitive announced FDA clearance for a labeling revision of its da Vinci X and Xi systems based on real-world evidence showing similar long-term survival rates for robotic-assisted and non-robotic radical prostatectomy. This collaboration with FDA, Aetion, and NEST highlights the potential of real-world data (RWD) in supporting regulatory applications and enhancing cancer treatment assessments and marks Aetion's first FDA device clearance and label change using RWD.