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ARTAS Hair Transplant Robot Gets FDA 510(k)Clearance-Hair Follicle Harvesting

Posted Apr 25 2011 8:47pm

This is quite a machine for hair transplants from the picture.  I guess we need a robot for almost everything any more and hair transplants seem to be no exception.  I tend to just want to ask the question, do we really need this, but image since it’s here I’m sure it will fill a need somewhere along the way <grin>.  This could be the next best thing to Propecia for all I know perhaps it does eyebrows too.  BD

From the website:

“ARTAS is an interactive, computer assisted system utilizing image-guided robotics to enhance the quality of hair follicle harvesting. Through its design and ease-of-use, ARTAS has the potential to solve most of the technical challenges inherent in the manual FUE technique. The image System is operated under the direction of a physician.”

“The ARTAS System combines several features including an interactive, image-guided robotic arm, special imaging technologies, small dermal punches and a computer interface. After the System is positioned over the patient's donor area of the scalp, ARTAS is capable of identifying and harvesting follicular units. The follicular units are stored until they are implanted into the patient's recipient area using current manual techniques.”

Medical device company Restoration Robotics has announced that it has received clearance from the FDA to market its ARTAS robot for use during hair transplant procedures.

The ARTAS system received 510(k) clearance from the FDA, meaning that the FDA ruled that ARTAS was “at least as safe and effective, that is, substantially equivalent, to a legally marketed device” that was not subject to full premarket approval.  This clearance is necessary before the device can be marketed.


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