News | July 12, 2000

FDA Clears Robotic Surgical System

The U.S. Food and Drug Administration has approved the first completely robotic surgical system for sale in the United States. The da Vinci surgical system, designed for use in laparoscopic procedures, is manufactured by Intuitive Surgical Inc. (Mountain View, CA).

Other complete medical robotic systems currently available in the United States can only be used in surgical procedures through an Investigational Device Exemption (IDE) study approved by the FDA.

A clinical trial that included 228 patients compared the da Vinci system to conventional laparoscopic techniques for removing the gall bladder and for surgically correcting gastroesophogeal reflux, or heartburn.

In addition, the FDA determined through review of Intuitive's Premarket Approval (PMA) application that this and future submissions for Intuitive's devices, including new clinical indications, could be reviewed through the 510(k) process.

"Since it looks like we're now on the 510(k) path, future clearances may require only 90 days versus a PMA approval which can typically take up to a year or more," said Fred Moll, medical director and co-founder of Intuitive Surgical.

Edited by Ursula Jones