U.S. robot surgery market gets a new player with FDA nod for Blue Belt Technologies

December 11, 2012 by MassDevice staff

Blue Belt Technologies enters the robot-assisted surgery market with an FDA win NavioPFS Surgical System for partial knee replacement.

Blue Belt Technologies' NavioPFS system

The U.S. robot-assisted surgery space added a new player this week with FDA clearance for Blue Belt Technologies' NavioPFS orthopedic surgery system.

The Pittsburgh, Pa.-based device maker won clearance with indication for partial knee replacement, a procedure generally performed using manual instruments, the company noted.

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Blue Belt plans to launch U.S. sales right away for partial knee replacement and to continue development in other applications for NavioPFS.

The device uses 3D visualization and intra-operative navigation to guide hand-held instruments, helping a physician precisely resurface bone during knee surgery.

"The entire Blue Belt team, including our physician advisors, has remained committed to providing orthopedic surgeons and hospitals a more precise and consistent technique to perform UKR procedures that takes into consideration the current economic environment in our healthcare system," president & CEO Eric Timko said in prepared remarks. " We are confident that NavioPFS accomplishes these goals, and provides excellent results for patients."

The system won CE Mark approval in the European Union in February 2012, and the NavioPFS has produced "excellent early clinical results" in trials in Belgium and the U.K., Blue Belt noted.

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