NMPA Approved 292 Medical Devices in April, Including Four Innovative Domestic Products from Recently IPO-Filing Companies

　　【Pharmaceutical Network Industry DynamicsAccording to the news released on the website of the National Medical Products Administration on May 9, in April 2024, the National Medical Products Administration approved the registration of 292 medical device products. Among them, there were 224 Class III medical devices produced in China, 37 imported Class III medical devices, 30 imported Class II medical devices, and 1 medical device product from Hong Kong, Macao, and Taiwan.
 

Among the 224 domestically produced third-class medical device products approved in April, there are four innovative products: magAssist's "Extracorporeal Ventricular Assist Device" and "Extracorporeal Ventricular Assist Pump Head and Tubing," SysDiagno Biotech's "Oligosaccharide Chain Detection Kit (Fluorescent Capillary Electrophoresis Method)," and Jiangsu Jingce Medical Technology Co., Ltd.'s "Combined Blood Glucose Meter."
 

Data shows that magAssist's extracorporeal ventricular assist device consists of a magnetic levitation motor, control host, and accessories, with the extracorporeal ventricular assist pump head and tubing.Centrifugal PumpComposed of a pump head, side-hole straight connector, Luer cap, tubing clamp, and zip ties. When used together, these two products form a bypass circuit connected to blood vessels. By controlling the main unit and using a magnetic levitation motor to drive the impeller inside the pump head to rotate in a suspended state, it provides kinetic energy for blood pressure enhancement, serving as a temporary extracorporeal mechanical circulatory support for patients after heart surgery. This product adopts full magnetic levitation blood pump technology, offering anti-vibration and anti-torsion performance, along with an optimized blood flow field design, effectively reducing the average incidence of blood compatibility-related complications.
 

SysDiagno Biotech's "Oligosaccharide Chain Detection Kit (Fluorescent Capillary Electrophoresis Method)" is a self-developed product in China. It uses capillary electrophoresis to qualitatively detect nine oligosaccharide chains in human serum samples, serving as an auxiliary diagnostic tool for primary hepatocellular carcinoma in patients with hepatitis B cirrhosis. This product facilitates the prevention and treatment of primary hepatocellular carcinoma through non-invasive testing methods.
 

Jingce Medical's "Combined Blood Glucose Meter" product consists of an invasive blood glucose detection module, a non-invasive blood glucose detection module, a metabolic heat probe, an environmental temperature and humidity monitoring module, and a display screen. As a supplement to existing fingertip blood glucose monitoring, it is suitable for daily self-blood glucose monitoring by patients with type 2 diabetes. The product estimates blood glucose concentration through non-invasive detection of metabolic heat levels, allowing diabetic patients to achieve blood glucose measurement by measuring the dynamic characteristics of deep oral temperature, which helps reduce patient discomfort and lower measurement costs.
 

In addition, the Class III domestic medical device products approved in April also include the semi-automatic external defibrillator from Shenzhen Anbao Medical Technology Co., Ltd.; the chromosome copy number variation detection kit (microarray chip method) from Hangzhou Ji Yi Mate Medical Device Co., Ltd.; the nucleic acid amplification detection analyzer from Jiangsu HuiXian Medical Technology Co., Ltd.; and the intracranial hemorrhage CT image-assisted triage software from Shenzhen Yiqi Medical Technology Co., Ltd.
 

Among the 37 imported Class III medical device products are Medtronic's innovative products: "一次性使用多极肾动脉射频消融导管" ("Disposable Multi-Pole Renal Artery Radiofrequency Ablation Catheter") and "肾动脉射频消融仪" ("Renal Artery Radiofrequency Ablation Generator").
 

Data shows that the disposable multi-pole renal artery radiofrequency ablation catheter consists of an electrode array, catheter, catheter handle, catheter connection cable, and straightening tool. The renal artery radiofrequency ablation generator consists of a generator, remote control, power cord, and DVI-D cable. These two products are used together, with the radiofrequency ablation generator transmitting radiofrequency energy through the catheter electrodes to the intima of the renal artery. Using the thermal effect of the current, it deactivates the sympathetic nerves surrounding the renal artery, blocking the transmission of sympathetic nerve excitement, thereby reducing the patient's blood pressure. This product lowers blood pressure by physically interrupting the transmission of sympathetic nerve excitement, effectively avoiding issues related to patient compliance and drug half-life compared to traditional drug treatments, providing a new auxiliary treatment option for patients with refractory hypertension.
 

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