09:33 AM EDT, 06/05/2024 (MT Newswires) -- Intuitive Surgical ( ISRG ) said Wednesday that the US Food and Drug Administration has approved a labeling update for da Vinci X and Xi specific for radical prostatectomy.

The labeling change is related to "the precaution for representative uses" statement for the da Vinci X and Xi systems, the company said.

The approval was based on real-world evidence collected between 2007 and 2014, demonstrating that the five- to 10-year survival rates after robotic-assisted radical prostatectomy are comparable to non-robotic procedures.

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