Peijia Medical Ltd. has received two marketing approvals from China’s NMPA for its catheters to be used in neurointerventional surgery. They are the balloon guide catheter (BGC) Fluxcap and delivery balloon dilation catheter Fastunnel. Both were developed by Peijia’s wholly owned subsidiary Achieva Medical Ltd.
Regulatory harmonization of artificial intelligence (AI) and machine learning (ML) is high on the checklist for companies that want to develop these products, but legislatures and regulatory agencies across the globe seem less interested. Koen Cobbaert, senior manager for quality standards and regulation with Royal Philips NV, told BioWorld that there is a race on to be the first market with a full-fledged set of regulations, a fact of life that does little to advance the cause of harmonization.
Shenzhen Xzing Technology Co. Ltd. received marketing approval from China’s NMPA for its Endofresh disposable electronic colonoscope. The disposable colonoscope provides images with 1920 x 1080 pixels, which helps with diagnosis. It is equipped with auxiliary water and a lens-washing function to make sure of clear vision throughout endoscopy. It also allows users to insert endoscopic accessories at any bending angle no more than 210 degrees.
Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors.
Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors.
The NMPA approved two different surgical robots for marketing, a step forward in growth of a sector that remains underdeveloped in China. One of the robots approved for marketing by the NMPA is from Yuanhua Orthopedic Robotic Ltd. and the other is Suzhou Microport Orthobot Co. Ltd. Both robots are used for total knee arthroplasty (TKA), removing damaged cartilage and bones from the surface of the knee joint and replacing them with artificial implants.
Acotec Scientific Holdings Ltd. has received marketing approval for its radiofrequency ablation system from China’s NMPA to treat varicose veins. The radiofrequency ablation system consists of an endovenous radiofrequency catheter and a radiofrequency generator.
China’s NMPA has given a green light for Walvax Biotechnology Co. Ltd.’s human papillomavirus (HPV) bivalent vaccine to be used against HPV types 16 and 18 to prevent cervical cancer.
China’s NMPA has given a green light for Walvax Biotechnology Co. Ltd.’s human papillomavirus (HPV) bivalent vaccine to be used against HPV types 16 and 18 to prevent cervical cancer.
China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform Beijing Meiyan Kongjian Biology Medicine Co. Ltd. The certification is for three scar repair products, four medical dressing and patch products, as well as three skin repair products.
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