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ClaroNav Kolahi Inc. (CKI), a Toronto-based developer and manufacturer of surgical navigation technology, has received certification under the EU Medical Device Regulation (MDR) for its Navient Surgical Navigation System. The certification covers the Navient Image Guided Navigation System and its reusable surgical instruments, allowing CKI to continue offering Navient across the European Union under the MDR framework. Navient was previously certified under the EU MDD.
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Navient, which supports spine, cranial, ENT, and biopsy procedures, also holds approvals including U.S. FDA, Health Canada, China NMPA, and Japan PMDA. CKI reports an installed base of more than 250 systems in over 70 countries.
For spine surgery, the company has added FluoroGuide 2D and what it describes as the first in-market CT/MRI to Fluoro Registration technology, which combines preoperative CT and MRI with intraoperative 2D fluoroscopy for 3D navigation. CEO Ahmad Kolahi said the approach is meant to “make navigation more accessible and affordable” by letting hospitals and ambulatory surgery centers use the conventional 2D C-arm they already own. The company also points to reduced radiation exposure for patients and operating room staff.
For CKI, the certification preserves access to its European customers. For the broader MedTech space, it reflects the ongoing work of moving established products from MDD to MDR, a step many manufacturers are still completing, alongside a push to make navigation viable outside centers with costly intraoperative 3D imaging.
