Recently, the National Medical Products Administration's Device Review Center released the results of the special review application for innovative medical devices (No. 2 of 2025), intending to approve 9 medical devices to enter the innovation channel.

1. Peripheral arterial stent graft system: Jiangsu Pupeng Medical Technology Co., Ltd
Pupeng Medical was established on December 16, 2019, and is a subsidiary of Jiangsu Zhenyi Medical Technology Co., Ltd. (hereinafter referred to as Zhenyi Medical). It is reported that Zhenyi Medical focuses on the cardiovascular disease field with extremely high mortality and disability rates, and the domestic market is still blank. Its business comprehensively covers multiple interventional treatment fields such as heart valves, peripheral and coronary arteries. It is the first platform enterprise to achieve one-stop innovative solutions for blood flow management on a global scale.

In addition to the products that entered the innovation channel this time, Park Peng Medical also has a heavyweight product approved for market on November 21, 2024, the peripheral intravascular shock wave system - DEEPQUAKE ™ Three types of certificates have been approved, adding another dark horse to the domestic peripheral vascular lithotripsy (IVL) track.

The working principle of this intravascular shock wave therapy device is different from traditional methods for treating calcified lesions. It uses low-pressure balloon dilation to release non focused pulsed acoustic pressure waves into the lesion, in order to crush calcified plaques on the wall of the tube. It also has a large pulse energy, multiple electrode arrangements, and a longer balloon length to choose from, providing more treatment options.

2. Peripheral drug-eluting stent: Shanghai Changde Medical Technology Co., Ltd
EF Number entering the innovation channel this time ® The peripheral drug-eluting stent is a self-developed achievement of Changde Medical. Its design fully considers the anatomical characteristics of the femoral popliteal artery, with a closed-loop structure at the proximal end to enhance support and improve positioning accuracy, and an open-loop structure at the distal end to adapt to the complex vascular conditions of the femoral popliteal artery. The drug coating is composed of paclitaxel and highly biocompatible fluoride, utilizing the sustained-release properties of fluoride to achieve long-term therapeutic effects with lower drug loading. In addition, the stent adopts a unique spraying technology to achieve gradient drug loading, thereby achieving the goals of targeted drug delivery and precise treatment. The conveying system adopts an innovative four axis design, which improves overall stability and support to better cope with complex bending lesions.

At present, Changde Medical has established a comprehensive product matrix in the field of interventional treatment for lower limb arterial stenosis, including EF Shine, which has been launched in China and applied in clinical practice ® Constrained balloon dilation catheter and EF Yangtze for patients who have completed pre-market clinical trials ® Subcutaneous rapamycin drug balloon catheter.

3. Absorbable hemostatic gel: Haining Jurassic Biotechnology Co., Ltd
Jurassic Biotech was founded in August 2019, mainly engaged in the research and production of medical colloidal materials and medical devices. At present, its main products are biomaterials medical devices used for human tissue occlusion and repair.

It is reported that in the 2024 national key research and development plan "diagnostic equipment and biomedical materials" key project selected by the China Biotechnology Development Center of the National Health Commission in January this year, its "research and development of absorbable hemostatic gel products based on strong wet surface tissue adhesion mechanism" project was successfully selected. It is reported that the feature of this product is that it can achieve hemostasis without relying on the body's own coagulation mechanism. At the same time, this is also a platform type biomedical material that can cover multiple indications such as pancreatic leakage prevention, cerebrospinal fluid leakage prevention, lung gas leakage prevention, and lymphatic leakage prevention in the future, providing safer and more effective solutions for hemostasis and moist wound closure and leakage prevention during surgery for patients.

4. X-ray computed tomography equipment: Neusoft Medical Systems Co., Ltd
Neusoft Medical was founded in 1998 and is positioned as a comprehensive solution provider for clinical diagnosis and treatment based on imaging equipment. It has four business lines: digital medical diagnosis and treatment equipment (CT, MRI, DSA, GXR, ultrasound, PET/CT, RT and core components), MDaaS (medical equipment and medical imaging data services) platform, equipment services and training, in vitro diagnostic equipment and reagents.

In December 2024, NeuBrainCARE II software from NeuBrain Medical was officially approved for Class III medical device registration by the National Medical Products Administration (NMPA) of China. This software is the second Class III certificate approved by Neusoft Medical in the field of stroke, and it is also the first software in China to have precise quantitative assessment function for post-stroke.

It is reported that NeuBrainCARE II software from Neusoft Medical is designed for imaging examinations of ischemic stroke and can provide key information on stroke treatment for imaging and clinical departments, including quantitative analysis of post-stroke, automatic ASPECT scoring, CTA collateral circulation analysis, MRA collateral circulation analysis, etc. It can automatically segment brain tissue, provide ASPECTS score, intelligently and quickly quantify, analyze the scope of early ischemic changes, evaluate the degree of early infarction in the anterior circulation, and has great value in evaluating whether patients are suitable for endovascular treatment, assisting doctors in treatment decision-making, prognosis analysis, and other aspects.

5. Percutaneous intervention cerebrospinal fluid diversion system: Sirevisk Corporation
CereVasc was founded in 2014 and is a medical device company dedicated to developing minimally invasive treatment plans for neurological disorders. On June 26, 2023, UniMed Medical established a partnership with CereVasc to obtain the exclusive development, sales and production of eShunt in Chinese Mainland, Hong Kong, Taiwan and Macao ® The rights and interests of the system.

eShunt ® The system is the percutaneous intervention cerebrospinal fluid diversion system that has entered the innovation channel. This system is the world's first minimally invasive implantable cerebrospinal fluid diversion device, which uses percutaneous intervention to fill the gap of traditional craniotomy cerebrospinal fluid diversion surgery. This system not only effectively reduces surgical risks, but also significantly shortens recovery time and reduces postoperative complications.

At present, eShunt ® The system has completed multiple clinical studies in North and South America, and the results have shown that it has good safety and efficacy. In the future, Lianmaide Medical will actively promote eShunt ® The system plans to conduct clinical research and market layout in China, establish a localized production and supply chain system, and collaborate with top domestic neurosurgery and neurointerventional experts in scientific research.

6. Boron neutron capture therapy system: Guoke Neutron Knife (Qingdao) Medical Technology Co., Ltd
Boron neutron capture therapy (BNCT) is an emerging and advanced tumor radiotherapy method that uses secondary particles produced by the nuclear reaction between neutrons and boron elements in the tumor to destroy cancer cells. It is a binary, targeted, and cell level precise treatment that combines radiation and drugs. While killing cancer cells, it greatly protects normal cells, especially suitable for difficult to treat cancers such as infiltration, spread, and metastasis.

It is reported that the BNCT equipment of Guoke Neutron adopts a Radio Frequency Quadrupole (RFQ) linear accelerator, which is in line with the technology of Spallation Neutron Source RFQ accelerator. It is the mainstream development direction of BNCT technology and has the advantages of high output power, short treatment time, low energy, low radiation activation dose, low fast neutron content, safer for human body, good environmental adaptability, simple accelerator structure, small system volume, easy maintenance, simple retirement in the later stage, and safer clinical use. At present, the device has passed the environmental impact assessment and obtained a radiation safety permit.

7. Ophthalmic surgical assistance system: Hangzhou Dishi Medical Biotechnology Co., Ltd
DiShi Medical was founded in July 2021 as a national technology-based small and medium-sized enterprise. The founding team comes from Germany's top global robotics and artificial intelligence laboratories, as well as a Fortune 500 German pharmaceutical company. As of now, DiShi Medical has applied for and authorized multiple US and Chinese invention patents, and has won several top global and domestic competition awards.

DiShi Medical's "DiShi WeiFeng" is the first ophthalmic surgical robot product in China to enter the multi center registration clinical trial stage. The multi center registration clinical trial was launched in June 2024, and the first batch of clinical trials was successfully completed. It is expected to become the first ophthalmic surgical robot approved for market in China.

It is reported that this product is the first flagship product launched by the micro operation robot platform created by Di Shi Medical. The robot system adopts a master-slave control mode to achieve precise and agile micro operations in a narrow and enclosed space of the eyeball. Combined with self-developed flexible microstructures and high-precision control algorithms, it has achieved a motion accuracy of up to 3 microns, becoming one of the highest precision micro surgical robots in the world.

8. Implantable tibial nerve stimulator: Shanghai Minimally Invasive Smooth Medical Technology Co., Ltd
Tibial nerve stimulator implantation is an internationally advanced therapy used to treat overactive bladder with/without urgency urinary incontinence. It is achieved by implanting an innovative leadless tibial nerve stimulator above the tibial nerve in the patient's ankle joint. Its internal structure is also very simple, including batteries and chips. Once implanted, it automatically provides routine stimulation to the nerves to stabilize the bladder and alleviate bladder overactivity.

Shanghai Minimally Invasive Smooth Medical Technology Co., Ltd. was established in 2021 and is headquartered in Shanghai. It is a technology-based enterprise specializing in the research and development of high-end medical devices such as nerve stimulators. One of the company's core products is implantable tibial nerve stimulator, which is mainly used to treat neurogenic bladder dysfunction, such as overactive bladder (OAS) and urinary incontinence.

9. Multi branch covered stent system for thoracic aorta: Shanghai Minimally Invasive Heart Meridian Medical Technology (Group) Co., Ltd
Xinmai Medical was founded in 2012 and was listed on the Science and Technology Innovation Board in 2019. It focuses on the research and development, production, sales, and service of aortic and peripheral vascular interventional medical devices, and has four subsidiaries, including Lanmai Medical ™ (Main peripheral venous business), Hongmai Medical ™ (Main peripheral arterial business), Tuomai Medical ™ (Main tumor intervention business) and US subsidiary.

At present, it has 13 products on the market, mainly including covered stents for thoracic and abdominal aorta, intraoperative stents, drug balloon dilation catheters, peripheral vascular stents, balloon dilation catheters, etc., of which 5 products have obtained CE certification.

Hector, the heavyweight product of Heartbeat Medical ® The multi branch covered stent system for the thoracic aorta is developed by Cardio Medical through its Castor technology ® Based on the development of a branched aortic stent graft and delivery system (the world's first approved integrated branched aortic stent graft), it is capable of endovascular reconstruction of the three branches of the aortic arch.

Source: https://news.yaozh.com/archive/45035.html