X-Guide® Receives EU MDR Certification for 3D Surgical Navigation System

X-Nav Technologies, LLC, a leading provider of dental surgical navigation systems, has announced a significant milestone: the X-Guide^® Dynamic 3D Surgical Navigation System is the first of its kind to receive certification under the European Union Medical Device Regulation (EU MDR) 2017/745. 

This certification underscores the company’s commitment to upholding the highest standards of quality and safety in dental technology.

Stringent Regulation

The EU MDR is recognized as one of the most rigorous medical device regulations globally, aimed at ensuring elevated levels of safety and quality in the development and production of medical devices within the European market. Compliance with this regulation necessitates a comprehensive assessment of a company’s Technical Documentation, Clinical Evidence, and Quality Management System, affirming that the X-Guide System meets the stringent requirements for clinical efficacy in dental surgical procedures.

Product: Navident 3 surgical navigation system

Kimberly Chan, Director of Regulatory Affairs and Quality Assurance at X-Nav Technologies, emphasized the significance of this achievement, stating, “This certification reflects X-Nav’s commitment to quality, safety, and performance that go into all products and processes.”

Commitment to Innovation

With the EU MDR certification, X-Nav is well-positioned to continue supporting its European clientele by providing hardware, software, and feature updates, as well as introducing future innovations aimed at enhancing surgical outcomes and patient care.

Edward Marandola, President and CEO of X-Nav Technologies, expressed pride in the company’s accomplishment, highlighting their dedication to delivering cutting-edge medical devices. He remarked, “It reflects our commitment as a global leader in delivering high-quality and innovative medical devices.”

The X-Guide Surgical Navigation System is renowned in the dental community for its unparalleled precision and reliability. Used by dentists and clinicians worldwide, the X-Guide facilitates more accurate and minimally invasive dental surgical procedures, ranging from single implant placements to full arch reconstructions.

ClaroNav Launches New Navident EVO Dental Navigation System

X-Nav Technologies operates on a global scale, with the X-Guide System available in over 50 countries and utilized by more than 50 universities worldwide. With 31 trademarks and 50+ patents, X-Nav continues to drive innovation in dental surgical navigation, aiming to improve patient outcomes and enhance the surgical experience for clinicians.

About X-Nav Technologies

X-Nav Technologies is dedicated to developing innovative image-guided surgical navigation and robotic-assisted products, striving to make dental procedures safer, more precise, and minimally invasive. With a commitment to advancing dental technology, X-Nav aims to empower clinicians to practice better dentistry and improve patient care.