NMPA Approves Four New Innovative Medical Devices, Bringing Total to 388

　　【Pharmaceutical Network Product InformationOn December 15, good news came again to China's medical device industry as the registration applications for four innovative medical device products were approved by the National Medical Products Administration. So far, a total of 388 innovative medical device products have been approved for marketing in China.
 

According to a message on the website of the National Medical Products Administration on December 15, recently, the National Medical Products Administration approved the registration applications for the implantable deep brain neurostimulator, implantable deep brain neurostimulation electrode leads, and implantable deep brain neurostimulation extension leads from SceneRay Co., Ltd.
 

The information shows that the implantable deep brain neurostimulator, when used in conjunction with the implantable deep brain neurostimulation electrode leads and the implantable deep brain neurostimulation extension leads, forms the implantable deep brain neurostimulation system. This system stimulates the nucleus accumbens and the anterior limb of the internal capsule, serving as an auxiliary treatment to prevent relapse in patients with refractory moderate to severe opioid addiction.
 

It is reported that in the field of opioid addiction treatment, there has long been a lack of physical intervention methods. Statistics show that in 2020, the number of people globally using opioids for non-medical purposes was approximately 61 million. The implantable deep brain stimulation system recently approved for Sceneray provides more treatment options for patients addicted to opioids. Compared with traditional drug therapy, this physical intervention method avoids the risk of drug dependence, bringing renewed hope to addicted patients and their families, and demonstrating the humanistic value of medical technology.
 

On the same day, the National Medical Products Administration (NMPA) also announced the approval of the proton therapy system registration application from Varian Medical Systems Particle Therapy Co.
 

The information shows that the product consists of an accelerator subsystem and a treatment subsystem. The accelerator subsystem includes the main accelerator system, energy selection system, and beam transport system, while the treatment subsystem comprises a 360° rotating beam treatment system and treatment planning system. It is suitable for treating systemic solid malignant tumors and specific benign conditions. The product adopts a compact cantilever gantry design, which can save space for proton equipment and improve treatment efficiency.
 

The密集 approval of two innovative devices has brought benefits to relevant patients. However, the accumulation of 388 innovative products bears witness to the qualitative change in China's domestically produced device industry. Nowadays, domestically produced devices have comprehensively advanced from basic consumables to high-end equipment. These breakthroughs not only reduce medical costs but also change the pattern of China's reliance on imported high-end medical devices.
 

It is reported that in December, before the approval of the aforementioned four innovative devices, two other innovative products were approved for marketing, including Taizhou Dubomai Medical Device Co., Ltd.'s "Single-Use Sterile Catheter" and Peijia Medical Limited's "Transcatheter Aortic Valve System." Among them, Peijia Medical's "Transcatheter Aortic Valve System" is suitable for patients assessed by the cardiac team as symptomatic, severe aortic regurgitation (greater than or equal to grade 3), who are not suitable for conventional treatment.Surgical OperationPatients with valve replacement aged 70 years or older. Taizhou Dubomai Medical "Single-Use Sterile Catheter," the outer surface of the catheter body is coated with polylysine. Based on the charge interaction mechanism between polylysine and the bacterial cell membrane, it exerts antibacterial effects through direct contact, reducing bacterial colonization and growth on the catheter surface.
 

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