Medtech receives FDA clearance for ROSA Spine robot
A company that specialises in designing, developing and marketing surgical assistance robots, has announced that it has received 510K clearance from the United States Food and Drug Administration (FDA) to market the ROSA™ Spine robot in the USA. Medtech will be allowed to promote the robot for minimally invasive surgical procedures on the spine.
Around three million such procedures are performed worldwide each year. Bertin Nahum, CEO and founder of Medtech, said: “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.
Source: Medical News Today