Medrobotics said today it won Australian TGA regulatory clearance for its Flex robot-assisted surgery platform, with indications for colorectal procedures.
The Raynham, Mass.-based company won indications for colorectal procedures from the FDA earlier this month, 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). 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. In 2015, Medrobotics started revolutionizing treatment in the head and neck in Australia. We can now begin doing that in colorectal procedures. Australian 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,” CEO Samuel Straface said in a press release.
In February, Medrobotics confirmed a $20 million funding round 1st reported by MassDevice.com in January. The company raised $25 million in November 2015. The latest round of $20.0 million, involving 12 unnamed investors, logged its 1st sale Jan. 20, according to a regulatory filing.