Medrobotics said today that it won 510(k) clearance from the FDA for a colorectal procedure indication for its Flex robot-assisted surgery platform.
The Raynham, Mass.-based company won expanded CE Mark approval in the European Union last October for Flex for performing colorectal procedures. 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). Medrobotics bills itself as the 1st robotics firm to offer minimally invasive and steerable robotic products for colorectal applications.
“The human gastrointestinal system is full of twists and turns, and rigid surgical robots were not designed to operate in that environment. The Flex robotic system was. Two years ago Medrobotics started revolutionizing treatment in the head and neck in the U.S. We can now begin doing that in colorectal procedures,” CEO Samuel Straface said today in prepared remarks. “American hospitals, surgeons and patients will be able to enjoy the benefits of the world’s only flexible, surgical robotic platform. It will easily integrate into hospitals due to its mobility and short learning curve.”
“The Flex robotic system offers the promise to treat select colorectal patients transanally with a more consistent and an easier approach because it overcomes the limits of straight surgical instrumentation,” added Dr. Alessio Pigazzi of the University of California, Irvine. “Medrobotics is ushering in the first of a new generation of shapeable and steerable robotic surgical systems that offer the potential to reduce the invasiveness of surgical procedures for more patients.”
Medtrotics said it’s developing new applications for the Flex system, including general surgery, gynecology and urology, that have yet to win a green light from the FDA.
In February the company confirmed a $20 million funding round 1st reported by MassDevice.com in January, saying it’s earmarked the proceeds for expanding into new areas including single-port general and gynecological procedures. The cash will also go toward developing the next iteration of the Medrobotics Flex “with more fully robotic instrument options,” the company said at the time.
Medrobotics raised $25 million in November 2015.