Medtech has received 510K clearance from the United States Food and Drug Administration to market the ROSA Spine robot in the U.S.
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 world-wide each year.
“We are thrilled to have FDA approval for ROSA Spine,” Medtech CEO Bertin Nahum said. “Building on the success that ROSA Brain has encountered on the Ameri-can 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 reﬂ ects our capacity to respect the commitments we made at the time of our IPO, growing as a company while offering innovative robotic technology.”
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.