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.

Bernstein Medical – Center for Hair Restoration has been using the ARTAS robot for FUE since December 2011.

The following is an excerpt of a press release about the ARTAS™ System by the developer of the device, Restoration Robotics, Inc.

ARTAS System Receives FDA Clearance for Ground-Breaking Technology Treating Hair Loss

Restoration Robotics, Inc., a medical device company that pioneered the first robotic follicular unit harvesting system, today announced that it has received FDA 510K clearance for its revolutionary ARTAS System


ARTAS System for FUE Hair Transplantation

Mountain View, CA – April 14, 2011 – Restoration Robotics, Inc. a privately-held medical device company, today announced that its revolutionary technology, the ARTAS™ System, has received 510K clearance from the Food & Drug Administration (FDA) for harvesting hair follicles from the scalp in men diagnosed with androgenetic alopecia (male pattern hair loss) with black or brown straight hair. The ARTAS™ System was developed in close collaboration with several leading hair restoration physicians to enhance the quality of follicular unit harvesting for the benefit of physicians and their patients.

“We are thrilled to receive FDA clearance, and look forward to rolling out the ARTAS™ System to leading hair restoration physicians,” said Jim McCollum, Chief Executive Officer, Restoration Robotics. “Hair loss is a very real issue for millions of men in the United States. We’re pleased to offer a powerful new technology for patients who are interested in a safe new way to enhance their quality of life.”

ARTAS™ is a physician-controlled, state-of-the-art, interactive, computer-assisted system that enables harvesting of hair follicles during hair restoration procedures. It combines several features including an image-guided robotic arm, special imaging technologies, small dermal punches, and a computer interface. The ARTAS™ System is capable of identifying and harvesting individual follicular units to implement the follicular unit extraction (FUE) technique.

Read more about developments in Robotic FUE

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

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