Coming Soon to an Abdomen Near You? TransEnterix Submits 510(k) Application for Surgical Robot

Surgical robot pioneer, TransEnterix, Inc., has submitted a 510(k) application with the U.S. FDA, aiming for clearance of its SurgiBot™ System.


TransEnterix is developing robotics and flexible instruments to improve minimally invasive surgery which it says address the economic and clinical challenges associated with current laparoscopic and robotic options. Transenterix’s stated goal is to usher in the next wave of minimally invasive surgery by delivering excellent instrument dexterity and precision, surgeon comfort, and minimize patient incisions.

In contrast to other robot-assisted surgical architecture, the SurgiBot system is the first-of-its-kind to allow the surgeon to be patient-side within the sterile field. The system is designed to be mobile, minimize reliance on additional staff, and be cost-effective for many types of surgical facilities.

The surgical approach and motions used with the SurgiBot are intended to mimic established laparoscopic surgical techniques. The system utilizes flexible instruments through articulating channels controlled directly by the surgeon, with robotic assistance, from within the sterile field. The flexible nature of the system allows multiple instruments to be introduced and deployed through a single incision.

Company comments 

“TransEnterix is pleased to deliver on our commitment to file for 510(k) clearance for the SurgiBot System by mid-2015,” said TransEnterix President and CEO, Todd M. Pope. “Robotically enhanced laparoscopy with the SurgiBot System represents the first surgical platform designed to address economic and clinical challenges associated with current laparoscopic and robotic options. We view the SurgiBot as a market-expanding technology with a compelling value for a wide variety of surgical facilities with the potential to deliver critical benefits to surgeons, hospitals and patients. We look forward to continuing our preparation to bring this innovative technology to the market upon FDA clearance.”

Source: Business Wire

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