Domestic Medical Devices Achieve Major Breakthroughs: Multiple Innovative Products Gain Regulatory Approval

　　【Pharmaceutical Network Industry DynamicsBy December 2025, a surge of innovative achievements will emerge in China's medical device industry. Among them, several medical devices independently developed in China will achieve significant breakthroughs.
 

Taking Rhino Health as an example, it recently obtained the registration certificates for disposable phacoemulsification kits and a phaco-vitrectomy integrated ophthalmic device. The latter is the first independently developed phaco-vitrectomy integrated machine produced in China, breaking the overseas monopoly. According to reports, the ophthalmic surgical system (registration number: Guo Xie Zhu Zhun 20253162583) approved this time by Rhino Health includes two specifications corresponding to the Rhino Health Genesis I and Genesis II products. This series of products are suitable for cataract extraction and vitrectomy in ophthalmology.
 

The number of patients with eye diseases in China is huge, with nearly 200 million cataract patients and 46 million patients with fundus diseases, and the demand for diagnosis and treatment is growing rapidly. However, in the past, the market for phacoemulsification and vitrectomy integrated machines was monopolized by foreign companies such as Alcon and Bausch + Lomb. Now, with the launch of Rhino Health's phacoemulsification and vitrectomy integrated machine, the competitive landscape of this market is about to change.
 

December 24th, news came that the National Medical Products Administration recently approved the registration applications for the interventional left ventricular assist device and the interventional left ventricular assist catheter pump kit, which were independently developed by Shenzhen Core Medical Technology Co., Ltd. The interventional left ventricular assist device and the interventional left ventricular assist catheter pump kit are used together to provide left ventricular assistance for high-risk percutaneous coronary intervention (PCI) in adult patients with severe coronary artery disease, reduced left ventricular ejection fraction, and stable hemodynamics.
 

It is reported that the system adopts miniaturized axial motor technology for short-term left ventricular assistance, which is a pioneering technology in China and fills the gap in domestically interventional cardiac assist devices. According to its registration clinical trial data, Core Medical's CorVad has demonstrated safety and efficacy comparable to or even better than existing devices in providing circulatory support during high-risk PCI procedures.
 

On December 24, the National Medical Products Administration announced that Hunan Antai Kangcheng Biotechnology Co., Ltd.'s Tumor Electric Field Therapy Device (Registration Certificate No.: 20253092649) has been officially approved for marketing. As the first China-produced approved product, it is suitable for patients aged 22 years or older with newly diagnosed supratentorial glioblastoma by histopathology or imaging. Following surgical and radiation therapy, its use in combination with Temozolomide (TMZ) can further improve patient outcomes.
 

In the past, due to the lag in domestic research and development, patients have long lacked domestically certified tumor electric field therapy devices that possess safety and efficacy. The launch of Antai Kangcheng's tumor electric field therapy device is expected to quickly change the current limitations of drug treatment for glioblastoma patients in China and break the dominance of imported products in the domestic market, offering a new treatment option for tens of thousands of malignant tumor patients in China each year.
 

On December 11, Bluesail Medical announced that "Stellar™", 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 recently obtained a medical device registration certificate.
 

The StarTrace™ Coronary Scoring Balloon Dilation Catheter, recently approved for Jiwei Medical, has shown remarkable performance in reducing the incidence of dissection and optimizing vessel preparation. Its advantages are particularly prominent for high-resistance complex lesions such as calcification, providing a safer and more ideal option for coronary interventional treatment.
 

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Overall, the recent approval of domestic medical device products fully demonstrates that the industry is rapidly developing towards high-end and precise directions. In the future, driven by strong policy support and endogenous market demand, China's medical device industry is expected to accelerate into a new stage of innovative development centered on high-end and globalization.
 

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