Medtech has been granted 510(k) clearance from the US Food and Drug Administration (FDA) to market the Rosa spine unit in the USA.
This clearance will allow Medtech to market the Rosa Spine robot in the USA for minimally invasive surgical procedures on the spine.
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 US for brain surgery in 2012. There are currently 27 Rosa Brain systems installed in American facilities.