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Restoration Robotics Receives FDA Clearance for Hair Loss Treatment

Restoration Robotics, a medical device company has announced that it has obtained FDA 510K Clearance for its ARTAS System, which would harvest hair follicles from the scalp of men diagnosed with androgenetic alopecia with brown or black straight hair.

This system was created with the help of several prominent hair restoration physicians to improve the quality of follicular unit harvesting, which would prove to be beneficial for the physicians and their patients. Jim McCollum, the CEO of Restoration Robotics, revealed that they were delighted to receive the FDA clearance and were waiting eagerly to commercialize and market the ARTAS Systems. He commented that hair loss was a distressing problem for millions of men in the US and this system would be a safe way for handling their hair problems and improving their life styles.

The ARTAS System was an innovative, physician controlled and computer assisted system that would ensure harvesting of hair follicles. It combined numerous features such as small dermal punches, an image guided robotic arm, a computer interface and special imaging technologies. This system could recognize and harvest individual follicular units for executing the follicular unit extraction method (FUE). Miguel Canales, the Medical Director of Restoration Robotics states that patients were always on the lookout for less invasive options and the FUE with its many benefits such as speedy return to normal life and much less discomfort would be an ideal choice for the patients. The ARTAS system would be the best answer for the physicians who face several technical challenges while using FUE.

Hair restoration is carried out by implanting hair and allowing them to develop their own blood supply and then grow. After a few months new hair would be seen and this growth phase would continue for the whole year after the procedure and thus change the patient’s look. James Harris from the Hair Sciences Center in Denver reveals that the ARTAS System would make hair restoration an attractive proposition to many more patients. Despite prescription remedies such as Rogaine and Propecia available, the only permanent treatment for hair loss was hair restoration.

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