Robot Hair-Transplant Device Gets FDA Nod


by Daniel J. DeNoon

reviewed by Laura J. Martin, MD

A robotic device for harvesting hair follicles now has a green light from the FDA. Sorry, Blondie and Curly — for the time being, it’s approved only for people with black or brown straight hair. Blond and curly-haired people were not included in the studies that led the FDA to give its 510(k) premarket notification, which allows sale of a device.

The device speeds the process of harvesting — removing — hair follicles from hairy parts of the head or body for later transplant to bald scalp. It can be used in a procedure called follicular unit extraction or FUE, an alternative to an older technique in which a strip of hair is removed and separated into smaller units for transplant. One problem with FUE is that it takes several hours, and sometimes multiple sessions, for a doctor to punch out the thousand or so tiny, two- to six-hair follicle units needed for a natural looking hair transplant. Another problem is that it’s very hard to tell exactly where the follicle lives. Guessing wrong results in slicing up a healthy follicle (what doctors call “transection”) and losing it forever. For these reasons, and because some people simply aren’t good candidates for FUE, many hair-restoration doctors prefer the older strip technique. But the strip leaves a scar across the back of the head, which is noticeable if a person wears his or her hair short. And the strip technique means longer recovery time for the patient.

Now Restoration Robotics Inc. says it has a better way to perform FUE: the Artas System. The Artas system has an image-guided robotic arm, special imaging technologies for guiding follicle-unit removal, small dermal punches, and a computer interface. It also corrects for slight patient motions.

The robot is expected to make FUE faster and easier on both the patient and the doctor. And because manual FUE is a very difficult technique to master, the robot is expected to make FUE easier to learn. Restoration Robotics says the cost of the device should be offset by the savings a doctor will realize from being able to do more FUE procedures with fewer assistants.

“We did demonstrate in the FDA trials the Artas System’s ability to meet equivalency in hair follicular survival, transection rates, and safety to current manual FUE techniques,” Miguel Canales, MD, medical director for Restoration Robotics, says in an email to WebMD.