Sonoscape Medical Corp. obtained marketing approval in China for its intravascular ultrasound (IVUS) diagnostic device and intravascular ultrasound diagnostic catheter.
Shanghai Microport Endovascular Medtech Co. Ltd.’s Hercules balloon dilation catheter has been approved for marketing approval in China to be used in endovascular aneurysm repair (EVAR) procedures.
Microport Neurotech Ltd.’s intracranial visualized stent Rebridge has been included in the green channel, a priority review for medical devices, by China’s NMPA.
As China seeks to be more independent in medical device development, authorities have released several guidelines to enhance the quality of its medical devices, as well as accelerate their registration.
Broncus Holding Corp.’s disposable nebulizing microcatheter for an endoscope has been approved by China’s NMPA. The product Mist Fountain is the only nebulizing micro-catheter product available on the Chinese market to treat lung disease, according to the company.
Tianjin Usights Ophthalmology Technology Co. Ltd.’s ophthalmic fiberoptic microcatheter system has been approved by the NMPA for marketing for minimally invasive glaucoma surgery (MIGS) in China. Tianjin, China-based Usights claims this is the first homegrown products for MIGS in China that has been approved.
Guangdong Pulse Medical Technology Co. Ltd. received marketing approval from China’s NMPA for its left atrial appendage (LAA) closure product called the Leftear occluder system.
Novo Nordisk A/S received marketing approval from China’s NMPA for its smart insulin pen Novopen Six that automatically collects and stores the date and time of injections and the number of units of insulin that users take.
Lepu Medical Technology (Beijing) Co. Ltd. received marketing approval from China’s NMPA for its peripheral cutting balloon to treat peripheral arterial disease.
