On May 23, the CFDA posted a news article "Implanted Vagus Stimulation Pulse Generator Kit and Implantable Vagus Nerve Stimulation Electrode Wire Kit Approved" on its official website home page. The full text is as follows: [On May 16, 2016, the State Food and Drug Administration reviewed and approved the "implanted vagus nerve stimulation pulse generator kit" and "implanted vagus nerve stimulation electrode lead kit" produced by Beijing Pinchi Medical Equipment Co., Ltd. Two products. The "implantable vagus nerve stimulation pulse generator kit" consists of a pulse generator, a test resistor, a torque screwdriver and a control magnet. The "implanted vagus nerve stimulation electrode lead set" consists of an electrode, a tunneling tool (including a puncture tool and a cannula), and a retaining clip. The combination of the above two products can play a role in controlling seizures in patients with refractory epilepsy whose drugs cannot be effectively controlled. It is the first domestically produced product of vagus nerve stimulation for epilepsy. The food and drug supervision and administration department will strengthen the supervision of products after listing and protect the safety of patients. CFDA has to approve so many products every month. Why are these two separate articles and are still hanging in prominent positions? National project, Tsinghua University is responsible for research and development Let's take a look at the origin of these two products. "People's Daily" previously reported that under the support of the "Twelfth Five-Year" National Science and Technology Support Program, China's only national neuromodulation research institute, the National Engineering Laboratory for Neuromodulation Technology, has undertaken the research and development of domestic vagus nerve stimulators. Tsinghua University is responsible for research and development, and Beijing Pinchi Medical Equipment Co., Ltd. is responsible for industrialization. The leader of the R&D team, the director of the National Engineering Laboratory of Neuromodulation Technology, is a professor at Tsinghua University, Li Luming. In addition to Tsinghua University, Beijing Labus Medical Equipment Co., Ltd. (hereinafter referred to as Pinchi) and Beijing's well-known top three hospitals, Tiantan Hospital, participated in the joint construction. The so-called national project, "production-study-research-medicine" is closely combined, and the two products approved by CFDA are the same.
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