Restoration Robotics, Inc., announced today that it received CE Mark approval for the sale of the ARTAS iX™ System with implantation functionality in Europe. The CE Mark approval follows the Company’s receipt of ISO 13485:2016 Certification for ARTAS iX in January 2019.
Ryan Rhodes, President and Chief Executive Officer of Restoration Robotics, states:
We are very pleased to announce our receipt of CE mark approval, which further expands our addressable market for ARTAS iX. With this approval ARTAS users in Europe will have the ability to leverage our new platform which includes novel implantation functionality, optimizes clinical outcomes, and further improves hair restoration process workflow. In these geographies, we will continue to sell through our international sales team and our distributor partners, as we maintain our focus on expanding our commercial presence globally.”
The ARTAS® Robotic Hair Restoration System is the first and only hair restoration system in the world combining robotic and artificial intelligence technology designed to assist surgeons through the most significant and tedious stages of the hair restoration process. It allows for precise, efficient, and repeatable hair restoration and automates the most significant aspects of hair transplantation procedures: graft harvesting, recipient site making, and now, implantation. ARTAS iX™ features an advanced stereoscopic machine vision system with improved 44-micron resolution and a 7-axis robot arm to deliver unmatched procedural analysis, precision, repeatability, and clinical workflow efficiency.