FDA OKs Intuitive Revised da Vinci Xi and X Labeling on Radical Prostatectomy

 Intuitive (NASDAQ:ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced today that the U.S. Food and Drug Administration (FDA) cleared a labeling revision for da Vinci X and Xi specific to radical prostatectomy. This clearance was based on real-world evidence (RWE) collected from 2007 to 2014 that demonstrates overall five- to 10-year survival following robotic-assisted radical prostatectomy is similar to non-robotic radical prostatectomy.

In a public-private collaboration, Intuitive worked with the FDA, healthcare analytics company Aetion, and the National Evaluation System for health Technology (NEST), utilizing its NEST Mark process to support the validity of the real-world data used in the labeling revision submission. This project demonstrated the utility of this type of collaboration in generating high-quality RWE to support marketing applications to the FDA and could allow for similar comprehensive long-term survival assessments for other cancer procedures, which helps advance regulatory science.

https://www.globenewswire.com/news-release/2024/06/05/2893853/7637/en/Intuitive-Announces-FDA-Clearance-of-Revised-da-Vinci-Xi-and-X-Labeling-on-Radical-Prostatectomy.html