06.01.15
TransEnterix Inc. a medical device company developing robotics and flexible instruments to improve minimally invasive surgery, has submitted its 510(k) application to the U.S. Food and Drug Administration (FDA) for clearance of the company’s SurgiBot system.
“TransEnterix is pleased to deliver on our commitment to file for 510(k) clearance for the SurgiBot System by mid-2015,” said Todd M. Pope, president and CEO. “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.”
According to the company, SurgiBot is the first patient-side, robotically enhanced laparoscopy platform. 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 uses 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, according to officials from the Research Triangle Park, N.C.-based company.
“TransEnterix is pleased to deliver on our commitment to file for 510(k) clearance for the SurgiBot System by mid-2015,” said Todd M. Pope, president and CEO. “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.”
According to the company, SurgiBot is the first patient-side, robotically enhanced laparoscopy platform. 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 uses 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, according to officials from the Research Triangle Park, N.C.-based company.