ROBOTIC
X-GUIDE IS THE FIRST DENTAL SURGICAL NAVIGATION SYSTEM TO RECEIVE EU MDR CERTIFICATION
X-Nav Technologies has announced that the X-Guide Dynamic 3D Surgical Navigation System is the first of its kind to receive certification under the European Union Medical Device Regulation 2017 / 745 , commonly referred to as EU MDR .
The EU MDR is one of the most rigorous medical device regulations in the world today , intended to ensure a higher standard of safety and quality in the development and manufacturing of medical devices distributed in the European market .
The regulation requires a thorough audit of a company ’ s Technical Documentation , Clinical Evidence , and Quality Management System . The completion of this process certifies that the X-Guide System delivers the claimed clinical benefits for dental surgical procedures , including dental implant surgery and endodontic access .
“ This certification reflects X-Nav ’ s commitment to quality , safety , and performance that go into all products and processes ,” said Kimberly
Chan , Director of Regulatory Affairs and Quality Assurance at X-Nav Technologies . “ I am pleased to see our high standards rewarded with this distinction . We are honoured to be a leader in our field and among the top medical device companies capable of meeting this regulation .”
With EU MDR certification , X-Nav is in a unique position to support our European customers , partners , and patients with hardware , software and feature updates , as well as deliver future innovations that will drive value for our customers .
“ I am proud of the in-house X-Nav team for their dedication and collective efforts in achieving this milestone for the business ,” said Edward Marandola , President and CEO of X-Nav Technologies . “ It reflects our commitment as a global leader in delivering high-quality and innovative medical devices . This sets us up to deliver our roadmap of future surgical solutions .”
X-Guide is a surgical navigation system used by dentists and clinicians around the world to deliver more accurate and less invasive dental surgical procedures with precision . From single implant placement to full arch reconstruction , the X-Guide delivers precision , control , and confidence during surgery .
The X-Guide Surgical Navigation System is available in 23 languages and 50 + countries , holds 31 trademarks and 50 + patents , and is used by over 50 universities around the world . �
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