Restoration Robotics (NSDQ:HAIR) said that it has successfully completed its ISO 13485:2016 audit and is compliant with CE Mark requirements for the sale of the ARTAS iX robotic system for hair implantation in Europe. The Company shipped the first ARTAS iX systems to customers in Europe in December 2018.
The Artas iX system has a 3-camera stereoscopic vision system with 44-micron resolution and a 7-axis robot. It has a compact, motorized, battery-powered, portable and adjustable procedure chair for increased patient comfort and can be used ergonomically in multiple aesthetic procedures.
Restoration Robotics (San Jose, Calif.) designed the Artas iX to deliver high-quality procedural analysis, precision, repeatability, and clinical workflow efficiency for hair restoration. It could also reduce the more labor-intensive aspects of hair restoration procedures as well as clinical fatigue and case time, according to the company.
“This certification and our first shipments of the ARTAS iX system to customers in Europe further validate our technology and represent two critical milestones ahead of final CE Mark approval,” said Ryan Rhodes, president and CEO of Restoration Robotics. “We look forward to further expanding access to our cutting-edge robotic hair restoration technology with implantation functionality while driving system sales globally.”
The company’s share price climbed from 49¢ to 67¢ on the news late yesterday.