ClaroNav Kolahi—a subsidiary of ClaroNav—has received regulatory clearance from the National Medical Products Administration (NMPA) to market and sell its Navient cranial model in China. Previously, the company had received NMPA approval for its Navient ENT model.
Navient, an image-guided surgical navigation system, is like a global positioning system (GPS) enabling surgeons to navigate inside a patient’s skull, according to a ClaroNav press release. It provides three-dimensional visualisation and assists surgeons with finding a way inside the skull and navigating their way safely to the diseased area.
“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 US FDA [Food and Drug Administration], European CE certification, Health Canada, Korean MFDS [Ministry of Food and Drug Safety], Brazilian ANVISA [Agência Nacional de Vigilância Sanitária] and Taiwan FDA,” said Ahmad Kolahi, CEO of ClaroNav Kolahi.
“Navient has been designed with simplicity and ease of use in mind. The result is a product that enables 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.”