Domestic Innovative Medical Devices Surge in Q1 2026: Breakthroughs in Brain-Computer Interfaces, Cardiovascular and Other High-End Fields

　　【Pharmaceutical Network Industry DynamicsIn recent years, with the continuous release of policy dividends, the acceleration of industrial cluster maturity, and the continuous improvement of the innovation ecosystem, the development of China's innovative medical device industry is continuously improving. According to statistics, in 2025, the National Medical Products Administration approved the listing of 76 domestically produced innovative medical devices, covering multiple cutting-edge fields such as artificial intelligence, tumor radiotherapy, and biomedical materials.
 

In the first quarter of 2026, the field of domestically produced innovative medical devices continued the strong momentum from 2025, with at least 10 products approved for marketing. Among them, multiple products achieved significant breakthroughs in advanced fields such as interventional treatment, brain science, and medical imaging.
 

On March 31, the National Medical Products Administration approved the registration application for the cryoablation system and the single-use balloon-type cryoablation catheter from Synaptic Medical Technology (Beijing) Co., Ltd. The cryoablation system, used in conjunction with the single-use balloon-type cryoablation catheter, is intended for treating adult patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
 

March 25 news: Amet Medical's innovative product registration application for the carbon dioxide contrast pressure injection set has been approved. The product consists of a contrast injector, infusion tubing, and dual-lock connectors.FilterComposed of three parts, used for injecting carbon dioxide (purity ≥ 99.999%) into the renal artery, iliac artery, lower limb artery, forearm vein, inferior vena cava, and iliac vein for angiography. Suitable for individuals allergic to iodine contrast agents, patients with chronic kidney disease stages 3 to 5, and patients with hyperthyroidism.
 

On March 24, Enlight Medical Limited's innovative product registration application for the transcatheter mitral valve clip system was approved. The product consists of a mitral valve clip and catheter delivery system, and a steerable guiding catheter; it is delivered percutaneously and is suitable for patients assessed by the cardiac team to have...Surgical OperationHigh-risk patients with degenerative mitral regurgitation (MR≥3+) and suitable mitral valve anatomy.
 

On March 13, the congenital nystagmus treatment device "i-NYS Implantable Ocular Muscle Neurostimulator" developed by Super Vision Technology, Inc. obtained the Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA) and was approved for marketing in China. The clinical trial results show that i-NYS can effectively increase the foveation time of patients with congenital nystagmus, significantly improve nystagmus symptoms, enhance visual quality, and demonstrate efficacy and safety in treating congenital nystagmus.
 

On March 13, the website of the National Medical Products Administration announced that the registration application for the innovative product NEO (Neuracle's Implantable Brain-Computer Interface Hand Motor Function Compensation System) had been approved. The product consists of an implantable brain-computer interface, an implantable electroencephalogram (EEG) electrode kit, an EEG signal transceiver, a pneumatic glove device, a disposable surgical tool kit, EEG decoding software, medical testing software, and clinical management software. It is mainly applicable to patients with quadriplegia caused by cervical spinal cord injury, assisting in achieving hand grip function compensation through the pneumatic glove device.
 

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Notably, in addition to the already approved products, multiple batches of products entered the special review process for innovative medical devices (also known as the "green channel") in the first quarter, such as the shock wave valve treatment system, magnetic resonance imaging system, self-expanding thoracolumbar fixation system, human special blood type genotyping test kit, pelvic fracture surgical planning software, and more.
 

The industry believes that in the first quarter of 2026, China-produced innovative medical devices have achieved multi-point breakthroughs in many high-end fields, marking that China’s substitution has moved from "low-value consumables" to a new phase of innovative devices with "high technological barriers." With the continuous acceleration of innovation by medical device companies and the successive transformation of a large number of reserve products in the "green channel," the number of approved innovative devices in 2026 is expected to reach a new high for the entire year.
 

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