Medrobotics said today that it won an expanded indication from the FDA for its Flex robot-assisted surgery device, adding robot-assisted visualization in general surgical, gynecological and thoracic procedures to its 510(k) clearance.
Raynham, Mass.-based Medrobotics won expanded CE Mark approval in the European Union in October 2016 for Flex for performing colorectal procedures; the system won 510(k) clearance from the FDA for transoral procedures in July 2015 after winning n CE Mark approval for that indication back in March 2014.
“With this new FDA indication, the use of Medrobotics’ flexible robotic technology extends beyond natural orifices,” CEO Samuel Straface said in prepared remarks. “This clearance is a vital step in our commitment to minimize the impact of surgery by offering less invasive procedures through a single incision in the abdomen or thoracic cavity versus the multiple incisions that are currently required.”
Medrobotics said it’s pursuing other expanded indications, including transvaginal gynecologic procedures.