SAN JOSE, Calif. — Restoration Robotics Inc. announced today that it received CE Mark approval for the sale of the ARTAS iX robotic hair-restoration 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.
Restoration Robotics said its ARTAS iX 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 added that it has unique expertise in machine vision, image guidance, visual servoing, and robotics, as well as developing intuitive interfaces to manage these technologies. ARTAS iX is currently approved in Europe and the U.S.
In March, Restoration Robotics said it is merging with Venus Concept.
The Robot Report has launched the Healthcare Robotics Engineering Forum, which will be on Dec. 9-10 in Santa Clara, Calif. The conference and expo focuses on improving the design, development and manufacture of next-generation healthcare robots. Learn more about the Healthcare Robotics Engineering Forum.
ARTAS iX includes new implantation ability
“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,” stated Ryan Rhodes, president and CEO of Restoration Robotics. “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.”
According to Restoration Robotics, the ARTAS system combines robotics and AI 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, now including implantation, claimed the company.
ARTAS iX features an advanced stereoscopic machine vision system with improved 44-micron resolution and a seven-axis robot arm to deliver unmatched procedural analysis, precision, repeatability, and clinical workflow efficiency, said Restoration Robotics.