Medtech, a company that designs, develops and markets surgical assistance robots, has received 510K clearance from the U.S. Food and Drug Administration (FDA) to market the Rosa Spine robot in the United States.

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. Approximately 3 million such procedures are performed worldwide each year, according to Medtech executives.

“We are thrilled to have FDA approval for Rosa Spine. Building on the success that Rosa 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," said Bertin Nahum, CEO and founder of Medtech. "In addition, the FDA approval reflects our capacity to respect the commitments we made at the time of our IPO, growing as a company while offering robotic technology.”

Rosa Spine received the CE Mark in 2014 and currently is 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 in France 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 United States for brain surgery in 2012. There are currently 27 Rosa Brain systems installed in American facilities, Medtech officials noted.

Founded in 2002, Medtech is based in Montpellier, France.

Watch the video below to learn more about the Rosa Spine system: