ClaroNav Kolahi Inc (CKI) has announced that it has received Health Canada approval for its Navient ENT and Navient Cranial as Class III medical devices. Previously both devices had been approved as Class II devices.
“Navient is one of the very few image guided navigation systems approved by Health Canada as a Class III device. Upgrading our license to a higher class demonstrates our deep commitment to product quality and safety.” said Ahmad Kolahi, CEO of CKI “CKI is dedicated to innovation and developing state-of-the-art image guided navigation systems to enable surgeons to confidently make more informed decisions for better patient outcomes. Our primary goal is to offer an intuitive, accurate and affordable product and make it standard-of-care around the world.”
Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Navient system is intended for cranial surgeries (such as craniotomies, cranial biopsies, tumor resections…) as well as ENT procedures (all trans-nasal cases such as transsphenoidal procedures, ethmoidectomies, frontal sinusotomies…).
Source: ClaroNav Kolahi Inc.