China's Medical Device Industry Gains Momentum with Surge in Innovative Product Approvals in 2025

　　【Pharmaceutical Network Industry DynamicsIn recent years, the medical device industry in China has been showing a positive trend of accelerated approvals, advanced technology, and deepening localization. According to reports, since December 12, the National Medical Products Administration (NMPA) has approved several innovative medical devices with original technology for marketing, including ATKC's Tumor Electric Field Therapy Device, Core Medical's Interventional Left Ventricular Assist Device, and the Interventional Left Ventricular Assist Catheter Pump Kit.
 

December 26, News: The National Medical Products Administration has approved the registration applications for two innovative products from Shenzhen Core Medical Technology Co., Ltd. (hereinafter referred to as "Core Medical"): the interventional left ventricular assist device and the interventional left ventricular assist catheter pump kit. The interventional left ventricular assist device and the interventional left ventricular assist catheter pump kit are used in combination for high-risk percutaneous coronary intervention (PCI), providing left ventricular assistance to adult patients with severe coronary artery disease, reduced left ventricular ejection fraction, and stable hemodynamics.
 

This system adopts miniaturized axial motor technology for short-term left ventricular assistance. It is a pioneering technology in China, filling the gap in domestically produced interventional cardiac assist devices.
 

On December 24, the National Medical Products Administration approved the registration application for the tumor electric field therapy device independently developed by Hunan Antai Kangcheng Biotechnology Co., Ltd. (hereinafter referred to as ATKC), becoming China's first tumor electric field therapy equipment specifically for the treatment of glioblastoma, which is expected to improve the accessibility of treatment for patients.
 

The product consists of a main unit, a junction box, disposable electrode pads, a power adapter, a lithium-ion battery, and a charging dock. It generates an alternating electric field at a fixed frequency for application to the brain. It is suitable for patients aged 22 years or older with newly diagnosed supratentorial glioblastoma by histopathology or imaging, and is used in combination with temozolomide (TMZ) after surgical and radiation therapy.
 

On December 15, three products developed by Suzhou SceneRay Medical Co., Ltd.—the "Implantable Deep Brain Neurostimulator," "Implantable Deep Brain Neurostimulation Electrode Leads," and "Implantable Deep Brain Neurostimulation Extension Leads"—were approved for marketing through the National Innovative Medical Device Review and Approval Channel.
 

This system is China's first invasive brain-computer interface product for the treatment of addiction-related mental disorders. It can be used as an auxiliary treatment to prevent relapse in patients with refractory, moderate to severe opioid addiction, offering more options for the treatment of opioid addicts.
 

On December 11, Bluesail Medical announced that "StellarMark™", a Class III medical device product named "Coronary Scoring Balloon Dilatation Catheter" independently developed and produced by its subsidiary Shandong Jiwei Medical Products Co., Ltd. under the Cardiovascular Division, had obtained a medical device registration certificate.
 

The StarTrace™ Coronary Scoring Balloon Dilation Catheter features unique spiral-triangular scoring wires that enable 360° efficient pressure-focused dilation. As the coronary scoring balloon with the highest number of four scoring wires available on the market, it offers a larger scoring area, with a Rated Burst Pressure (RBP) of up to 20atm, providing greater safety during expansion. It excels in reducing the incidence of dissections and optimizing vessel preparation, demonstrating particular advantages in high-resistance complex lesions such as calcification.
 

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From a holistic perspective, the vitality of China's medical device industry continues to be unleashed. As of December 25 this year, 73 innovative medical devices have been approved, setting a new record high. These innovative medical devices focus on high-value consumables, intelligent diagnosis and treatment technologies, and cutting-edge diagnostic equipment, providing new solutions for clinical diagnosis and treatment.
 

In the future, with the continuous enhancement of innovation enthusiasm among medical device companies, the industry expects that the domestic substitution of high-value medical devices will hit the "acceleration button" for development. The entire industry will also enter a new phase of "parallel running" or even localized "leading" in independent innovation and cutting-edge leadership.
 

　　Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.