Health Canada Approves Navient Image-Guided Navigation Tech

ClaroNav Kolahi Inc.’s (CKI) image-guided navigation solution has cleared another regulatory hurdle. 

The company’s Navient ENT and Navient Cranial have been cleared by Canadian regulators as Class III medical devices (the pair previously had been approved as Class II products).

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). 
 
“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.”
 
 ClaroNav is a medical device hardware and software company focused on surgical navigation headquartered in Toronto, Canada. ClaroNav consolidates its technology and diversify its products across surgical specialties, geography, and distributions. Navient is represented worldwide by authorized distributors. ClaroNav is dedicated to innovation and developing state-of-the-art image guided navigation systems for surgeons.