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    Breaking News

    Navient Receives Chinese Regulatory Clearance for ENT Applications

    The surgical navigation system is already approved in the United States, Europe, Canada, South Korea, Brazil, and Taiwan.

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    Michael Barbella, Managing Editor02.22.21
    Add China to the list of regulatory approvals for ClaroNav Kolahi Inc.'s Navient ENT product. The company recently gained clearance from the National Medical Products Administration. 

    Navient, a computer-assisted surgical navigation system, is like a GPS for the surgeon to navigate inside the patient skull. It provides three-dimensional visualization and assists surgeons with finding their ways inside the patient sinuses and avoid critical structures such as the optic nerve and brain, while safely navigating their way to the diseased area. 

    “Navient is an innovative surgical navigation system offering a compact and truly portable cart, unparalleled accuracy, reusable instruments and simple workflow,” said Mr. Pan Wang, CEO at Nanning Xinzizhu Trading Co. Ltd., Navient’s exclusive distributor in China. “Navient’s powerful and intuitive software utilizes the latest technologies in the surgical navigation field and is aligned with our corporate strategy of benefiting Chinese patients and surgeons with advanced technologies.”

    Navient ENT previously has been cleared by the U.S. Food and Drug Administration, Health Canada, Korean Food and Drug Administration, Brazilian ANVISA and Taiwan Food and Drug Administration. The product also has received CE Mark approval in Europe.  

    “We are very excited that our Navient ENT product has been granted NMPA approval. It was a major milestone and it opens a significant market to our product,” said Ahmad Kolahi, CEO of CKI, a subsidiary of ClaroNav. “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.”
     
    CKI is a medical device hardware and software company headquartered in Toronto, Canada, and is represented worldwide by authorized distributors. CKI is dedicated to innovation and developing state-of-the-art surgical navigation systems.
     
    XZZ is Navient’s exclusive distributor in China headquartered in Nanning, capital of Guangxi Province in South of China. XZZ’s is focused on improving medical conditions in China by importing innovative and state-of-the-art international medical devices. XZZ’s marketing network covers more than 20 provinces around China, and services more than 50 hospitals.
     
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