China Clears Navient Neuro-Navigation System

ClaroNav Inc.’s Navient Cranial model has been cleared for use in China.

“Chinese NMPA approval opens a significant market to Navient. We are thrilled that our Navient product now has regulatory approval from all major regulatory agencies including the U.S. FDA, European CE, Health Canada, Korean MFDS, Brazilian ANVISA and Taiwan FDA,” said Ahmad Kolahi, CEO of ClaroNav Kolahi Inc., a subsidiary of ClaroNav Inc. “Navient has been designed with simplicity and ease of use in mind. The result is a product that enables the surgeons to operate the system more confidently and accurately. We are looking forward to working with our partner in China and making image-guided surgery standard-of-care in China.”

The company’s Navient system (an image-guided surgical innovation) had previously received Chinese approval for ENT applications. Navient acts like a GPS, enabling surgeons to navigate inside the skull. It provides three-dimensional visualization and assists surgeons with finding their way to the diseased area of a patient’s skull.
 
“Navient is an image-guided surgical navigation system offering an intuitive software workflow, accurate navigation, reliable hardware in a portable design. The product is well aligned with our corporate strategy of benefiting Chinese patients and surgeons with advanced technologies,” said Pan Wang, CEO at Nanning Xinzizhu Trading Co. Ltd., Navient’s exclusive distributor in China. “We are very excited in receiving Chinese NMPA approval and looking forward to further expanding our activities in China to provide the best service and support to our customers.”
 
ClaroNav is a medical device hardware and software company focused on surgical navigation headquartered in Toronto, Canada. ClaroNav is dedicated to innovation and developing state-of-the-art surgical navigation systems.
 
XZZ is Navient’s exclusive distributor in China, headquartered in Nanning. XZZ is focused on improving medical conditions in China by importing state-of-the-art international medical devices. XZZ’s covers over 20 provinces and services more than 50 hospitals.