X-Nav Technologies, LLC 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.

X-Nav Technologies，LLC宣布，X-Guide®动态3D手术导航系统是第一个根据欧盟医疗器械法规2017/745（通常称为欧盟MDR）获得认证的此类系统。欧盟MDR是当今世界上最严格的医疗器械法规之一，旨在确保在欧洲市场销售的医疗器械的开发和制造中达到更高的安全和质量标准。

X-Guide® Is The First Dental Surgical Navigation System  To Receive EU MDR Certification

X-Guide®是第一个获得欧盟MDR认证的牙科手术导航系统

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.

该法规要求对公司的技术文件、临床证据和质量管理体系进行彻底审计。这一过程的完成证明，X-Guide系统为牙科外科手术（包括牙种植手术和牙髓通路）提供了声称的临床益处。

'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 honored 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,' stated Edward Marandola, President and CEO of X-Nav Technologies.

X-Nav Technologies监管事务和质量保证总监金伯利·陈（KimberlyChan）说，该认证反映了X-Nav对所有产品和流程的质量、安全和性能的承诺我很高兴看到我们的高标准得到了这一殊荣。我们很荣幸成为我们领域的领导者，成为能够满足这一规定的顶级医疗器械公司之一。”凭借欧盟MDR认证，X-Nav在硬件、软件和功能更新方面为我们的欧洲客户、合作伙伴和患者提供支持，并提供将为客户带来价值的未来创新方面处于独特地位。”X-Nav Technologies总裁兼首席执行官爱德华·马兰多拉（EdwardMarandola）表示，我为X-Nav内部团队的奉献精神和集体努力感到骄傲。

'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.'The EU MDR certification is a notable addition to the existing portfolio of X-Nav's quality and regulatory accomplishments. You can learn more about X-Nav's commitment to quality programs by visiting www.X-NavTech.com/quality-regulation.X-Guide is the industry-leading surgical navigation system used by dentists and clinicians around the world to deliver more accurate and less invasive dental surgical procedures with remarkable precision.

“这反映了我们作为全球领先者在提供高质量和创新医疗设备方面的承诺。这为我们提供了未来手术解决方案的路线图。”欧盟MDR认证是对现有X-Nav质量和监管成就组合的显著补充。您可以访问www.X-NavTech.com/quality-regulation，了解更多关于X-Nav对质量计划的承诺。X-Guide是业界领先的外科导航系统，世界各地的牙医和临床医生都使用它来提供更准确，更少侵入性的牙科外科手术，具有非凡的精确度。

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.

从单种植体植入到全弓重建，X-Guide在手术过程中提供了精确度，控制力和信心。X-Guide手术导航系统有23种语言和50多个国家/地区，拥有31个商标和50多个专利，并被全球50多所大学使用。