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Medtech receives FDA clearance for surgical assistance robot for MIS in the spine

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Medtech recently announced it has received FDA 510(k) clearance for its ROSA Spine robot.

The FDA clearance will allow Medtech to market the spine robot in the United States for minimally invasive surgical procedures. The ROSA Spine robot received a CE mark in 2014, and the first procedure using the robot was performed in December of 2014.

“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. In addition, the FDA approval again reflects our capacity to respect the commitments we made at the time of our [initial public offering] IPO, growing as a company while offering innovative robotic technology,” Bertin Nahum, chief executive officer and founder of Medtech, said in a press release.

Reference:

www.medtech.fr/en/home