X-Nav Technologies, LLC has proudly announced that its X-Guide® Dynamic 3D Surgical Navigation System has become the first of its kind to obtain certification under the European Union Medical Device Regulation 2017/745, commonly referred to as EU MDR. This regulation is recognized as one of the most stringent standards globally, ensuring elevated levels of safety and quality in the development and distribution of medical devices across the European market. Compliance involves a thorough evaluation of Technical Documentation, Clinical Evidence, and Quality Management Systems.

The successful completion of this process validates the X-Guide System's ability to deliver promised clinical benefits for a range of dental surgical procedures, including dental implant surgery and endodontic access.

This certification underscores X-Nav's steadfast commitment to quality, safety, and performance across its entire product line. With EU MDR certification, X-Nav is uniquely positioned to provide support to its European customers, partners, and patients through hardware, software, and feature updates, as well as future innovations designed to enhance customer value. The X-Guide remains the leading surgical navigation system utilized by dentists and clinicians globally, enabling more precise and minimally invasive dental surgical procedures with unmatched accuracy.

From single implant placements to full arch reconstructions, the X-Guide ensures precision, control, and confidence during surgery. Available in 23 languages and over 50 countries, the X-Guide Surgical Navigation System has secured 31 trademarks and over 50 patents, and is utilized by more than 50 universities worldwide.

Source: prnewswire.com

 

 

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