Restoration Robotics Receives FDA Approval for FUE Hair Transplantation

June 27th, 2011

Restoration Robotics, Inc. — based in Mountain View, CA — has developed a robotic system for follicular unit extraction (FUE), called the ARTAS robotic system for hair restoration. The computerized device has received 510(k) approval from the Food and Drug Administration. Restoration Robotics is due to begin marketing the system for use in hair restoration clinics in the United States.

The FDA classifies the ARTAS robotic system for hair restoration as a “computer assisted hair harvesting system” and describes it as being used to identify and extract follicular units to aid the surgeon during hair transplant procedures.

The robot consists of a computer assisted station with needle mechanism, force sensor, robotic arm, and video imaging system. The software that runs the instrument helps the surgeon target follicular units for extraction and also uses stereoscopic video images to guide the needle mechanism and robotic arm.

At present, the device is used only for the graft harvesting aspect of the follicular unit transplant procedure.

Read more about robotics in FUE hair transplant surgery.


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Posted by Robert M. Bernstein M.D. on June 27th, 2011 at 5:47 pm



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