Surgical Robotics Technology

ClaroNav Secures Chinese Regulatory Clearance for Navient ENT


Leader in surgical navigation systems, ClaroNav Kolahi Inc., has received Chinese regulatory clearance from the National Medical Products Administration (NMPA) to market and sell its Navient ENT product in China. Navient ENT previously had been granted US FDA, European CE mark, Health Canada, Korean FDA, Brazilian ANVISA and Taiwan FDA.

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.”

“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.”

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