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FDA today cleared for marketing a robotic device that enables a surgeon to perform laparoscopic gall bladder and reflux disease surgery while seated at a console with a computer and video monitor. The surgeon can use hand grips and foot pedals on the console to control three robotic arms that can perform the surgery using a variety of surgical tools. The product, the Da Vinci Surgical System, made by Intuitive Surgical, Inc., of Mountain View, Calif., is the first of its kind. The robotic arms, which have a "wrist" built in to the end of the tool, giving surgeons additional manipulation ability during laparoscopic surgery, enabling easier, more intricate motion and better control of surgical tools. The new robotic system is intended to be used in an operating room in laparoscopic procedures, for example for gall bladder disease or gastro-ensophageal reflux disease (severe heartburn). FDA clearance was based on a review of clinical studies of safety and effectiveness submitted by the manufacturer and on the recommendation of the General and Plastic Surgical Devices Panel of FDA's Medical Devices Advisory Committee. Results showed that the robotic system was comparable to standard laparoscopic surgery in safety and effectiveness. Because of the expected learning curve with the new system, Intuitive Surgical is developing a training program for surgeons in collaboration with FDA.

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