Navient Receives FDA Clearance

Smart Solution for Enhanced Productivity

CKI (ClaroNav Kolahi Inc.) has received FDA 510(k) Clearance for Navient in ENT procedures, expanding its previous clearance for cranial applications. Navient is now approved by major global regulatory bodies including: Canada (HC), Europe (EU MDD), China (NMPA), UAE, Taiwan (TFDA), Mexico (Cofepris), Australia (TGA), Colombia (Invima), Peru, Turkey,….

 

Navient is an innovative image-guided navigation system that utilizes the latest technologies in surgical navigation systems and brings simplicity, accuracy, and affordability to the Cranial, Spine, and ENT navigation systems.

 

Key Features:



 General features:

  • Supports Spine, Cranial, Biopsy and ENT procedures
  • Sleek, compact, and portable cart
  • Large touch screen for natural interaction
  • Powerful and intuitive software features
  • Pre-calibrated navigation probes


Spine features:

  • 2D and 3D C-arm Integration for automatic registration
  • Automatic registration using intra-op CT and C-arm
  • Endoscopic Spine Navigation
  • AI-Powered automatic spine segmentation


Cranial and ENT features

  • Navient AIR Touchless registration
  • Tractography and advanced cranial planning
  • Navigated Biopsy and shunt placement 



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About ClaroNav Kolahi Inc. (CKI)

CKI is a medical device hardware and software company headquartered in Toronto, Canada, and is represented worldwide by authorized distributors. CKI is deeply committed to product quality and safety, and certified as compliant with ISO 13485, ISO 14971 and CMDCAS. CKI is dedicated to innovation and developing state-of-the-art surgical navigation systems to enable surgeons to confidently make more informed decisions for better patient outcomes.



Contact:

ClaroNav Kolahi Inc. (CKI)

1140 Shepard Avenue West

Toronto, Canada, M3K 2A2

Phone: + 1 (647) 951 1525

Website: https://medical.claronav.com/

Email: info@claronav.com