Medrobotics said today it submitted an application to the FDA as it seeks clearance for a flexible transabdominal robotic scope designed to visualize anatomy in the thoracic and abdominal cavities.
The Raynham, Mass.-based company produces the Flex robot-assisted surgery platform, which is designed for transoral, colorectal and other minimally invasive procedures. The company touts the system as the 1st to offer minimally invasive and steerable robotic products for colorectal applications.
Medrobotics said that the submission reaffirms its “commitment to develop products for single-port general, gynecological and urological surgeries, according to a press release.
In May, Medrobotics won indications for colorectal procedures with the Flex system from the FDA, and won similar expanded CE Mark approval in the European Union last October.
The system won 510(k) clearance from the FDA for transoral procedures in July 2015 (that indication won CE Mark approval back in March 2014).