FDA Green-Lights Medrobotics' Flex Robotic System For Transoral Head And Neck Surgery

03 Sep 2015

Medrobotics Corp. recently received US FDA 510(k) clearance for its Flex Robotic System for transoral head and neck surgery, a market estimated at roughly $1 billion in the US alone. Although Medrobotics is only the second company to bring a robotic soft-tissue surgical system to market in the US, other novel systems are in development, including a unique robotic system for needlescopic procedures.

In July, Medrobotics Corp. became the second company ever to receive FDA 510(k) clearance for a robotic soft-tissue surgical system. Unlike the da Vinci Surgical System from Intuitive Surgical Inc., which was approved in 2000 and uses rigid, straight instruments with articulating ends, the Flex Robotic System features a flexible scope and instruments that a surgeon can precisely direct with up to 180-degree turns through the body’s tortuous paths. In March 2014, the device received CE mark in Europe, where it has garnered great success, according to Medrobotics president and CEO Samuel Straface, PhD.

Flex was invented and then patented in 2005 by Carnegie Mellon University in Pittsburgh, PA, where Medrobotics was incubated,...