Medtech, a company specialized in designing, developing and marketing innovative surgical assistance robots, is pleased to announce that it has received 510K clearance from the United States Food and Drug Administration (FDA) to market the ROSA™ Spine robot in the United States of America.
Obtaining FDA clearance is a major step in Medtech's development strategy and will allow the Company to market the ROSA™ Spine robot in the United States for minimally invasive surgical procedures on the spine. Around 3 million such procedures are performed worldwide each year.
Bertin Nahum, CEO and Founder of Medtech, said: "We are thrilled to have FDA approval for ROSA™ Spine. Building on the success that ROSATM Brain has encountered on the American market, this new key regulatory milestone will allow us to strengthen our position in the world's leading market for spine surgery. In addition, the FDA approval again reflects our capacity to respect the commitments we made at the time of our IPO, growing as a company while offering innovative robotic technology."
ROSA™ Spine received the CE Mark in 2014 and is currently being used in minimally invasive spine surgery. The first commercial procedure in Europe was performed in December 2014 at the Neurosurgery Department of Amiens-Picardy University Hospital to treat a patient with a degenerative spine disorder through a lumbar fusion with a posterior approach.
The ROSA™ platform was previously approved in the U.S. for brain surgery in 2012. There are currently 27 ROSA™ Brain systems installed in American facilities.