ClaroNav Kolahi Receives EU MDR Certification for Navient Surgical Navigation System

ClaroNav Kolahi has received certification under the European Union Medical Device Regulation (MDR) for its Navient Surgical Navigation System, covering the Navient Image Guided Navigation System and its reusable surgical instruments, allowing the company to continue offering Navient throughout the European Union under the EU MDR regulatory framework.

Previously certified under the EU Medical Device Directive, Navient has received regulatory approvals from the U.S. FDA, Health Canada, China NMPA, and Japan PMDA. Currently, more than 250 Navient systems are installed in over 70 countries worldwide. The platform is used for spine, cranial, ENT, and biopsy procedures, combining advanced optical tracking, imaging integration, registration technologies, and AI-assisted surgical planning in a compact, portable design intended to make advanced navigation practical and accessible for a broader range of hospitals, ambulatory surgery centers, and outpatient surgical facilities.

For spine surgery, ClaroNav Kolahi has expanded the Navient platform with FluoroGuide 2D and its first-in-market CT/MRI to Fluoro Registration technology, integrating both preoperative CT and MRI with intraoperative 2D fluoroscopy for advanced 3D navigation.

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