Restoration Robotics® Secures ISO 13485:2016 Certification
Announces Shipment of first ARTAS iX™ Systems to Europe
San Jose, Calif., Jan. 02, 2019 (Globe Newswire) -- Restoration Robotics, Inc. (NASDAQ: HAIR), announced today that it has successfully completed its ISO 13485:2016 audit and is compliant with CE Mark requirements for the sale of the ARTAS iX™ System with implantation in Europe. The Company shipped the first ARTAS iX Systems to customers in Europe in December 2018.
Ryan Rhodes, President and Chief Executive Officer of Restoration Robotics, added, “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. We look forward to further expanding access to our cutting-edge robotic hair restoration technology with implantation functionality while driving system sales globally.”
The International Organization of Standards (ISO) is a non-government entity comprised of academic and industry professionals that certifies that companies are compliant with industry-standard best practices in their production and operations. Specifically, ISO 13485:2016 is an internationally recognized quality standard for a quality system to ensure customer and regulatory requirements are consistently met throughout the lifecycle of the medical device product.
About Restoration Robotics
Restoration Robotics, Inc. is a medical device company developing and commercializing the ARTAS® and ARTAS iX™ Robotic Hair Restoration System. The ARTAS iX System is the first and only physician-assisted system to dissect and assist in the harvesting of follicular units directly from the scalp, create recipient implant sites using proprietary algorithms and implant the hair follicles into the designated sites. The Company has unique expertise in machine vision, image guidance, visual servoing and robotics, as well as developing intuitive interfaces to manage these technologies.
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Restoration Robotics, Inc.
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