Robotics medical company TransEnterix filed its response to the Food and Drug Administration’s additional information request on its Senhance Surgical Robotic System 510(k) submission.
The Senhance robotic-assisted surgery system is designed to improve minimally invasive surgery, namely in laparoscopy operations, through haptic feedback and eye sensing camera control.
“We are very pleased to have submitted our AI response ahead of schedule, demonstrating our team’s effectiveness and our ongoing collaboration with the FDA,” president and CEO Todd M. Pope said in a press release. “The submission of our response is a key step towards achieving 510(k) clearance for the Senhance, which we continue to expect in 2017.”
TransEnterix filed the FDA 510(k) application in April following significant upgrades to the Senhance system, including making it compatible with the Stryker and Novadag vision systems. Pope was hopeful the application would be approved within six months.
The company acquired the Senhance system, originally named Telelap ALF-X, from Italy’s Sofar SpA in 2015. It already had a CE Mark approval in the European Union for minimally invasive surgery procedures.
The decision to purchase the the system followed the FDA’s denying TransEnterix’s 510(k) application for its own robotic surgery SurgiBot system, which aimed to the the first patient-side robotically-enhanced laparoscopy platform. The company ultimately shelved the SurgiBot in favor of developing and commercializing the Senhance system.
Tell Us What You Think!