Recently, the National Medical Products Administration's Device Review Center released the results of the special review application for innovative medical devices (No. 9 of 2024), intending to approve 7 innovative medical device projects to enter the special review process.1. Liver low-temperature perfusion system: Hangzhou Lepusheng Medical Technology Co., Ltd
Hangzhou Lepusheng Medical Technology Co., Ltd. (hereinafter referred to as Lepusheng Medical) was founded in 2016, focusing on the independent research and development of advanced medical devices for the protection, preservation, repair, and transportation of transplanted organs. It is committed to becoming a domestic benchmark and a global leading solution provider in the field of organ perfusion preservation and resuscitation.
Since its establishment, Lepusheng Medical has made breakthroughs in core technologies such as organ perfusion protection and transport repair, and is opening up a new model for organ protection in China. The research and development focus of Lepusheng Medical is on the perfusion preservation, resuscitation, and transportation technology of transplanted organs. The controlled perfusion preservation and resuscitation technology device system established by its research and development, as well as the specialized perfusion fluid developed, will achieve machine precision controlled perfusion preservation and real-time repair of clinical transplanted organs.
It is reported that its fully automatic organ preservation and repair equipment product technology is globally leading, including a series of products for repairing solid organs such as liver, kidney, heart, and lungs. Among them, the liver and kidney repair equipment is the world's smallest dual channel low-temperature fully automatic perfusion repair equipment, which can perform uninterrupted repair during organ transport.
This series of devices can achieve precise control and fully automatic feedback adjustment of the main physiological parameters and storage environment parameters of organs, and perform sustainable perfusion repair of transplanted organs in vitro. Real time monitoring and evaluation of various indicators of organs can effectively intervene in organ preservation damage, improve the quality of donor organs, and increase the time limit of organ transportation, making long-term and long-distance organ transportation possible. Simultaneously using this device for pre transplant repair of donated organs can improve the utilization rate of peripheral organs and save more patients.

2. Cardiac pulse electric field ablation catheter: Shenzhen Maiwei Medical Technology Co., Ltd
Shenzhen Maiwei Medical Technology Co., Ltd. (hereinafter referred to as Maiwei Medical) was established in July 2021. Based on 22 years of deep technical accumulation in the field of high-voltage pulses and 18 years of experience in ultrasound therapy, strong execution power, and ultra-high research and development efficiency, Maiwei Medical has quickly completed the development of four industry-leading multimodal energy platforms, including pulse electric field ablation, radiofrequency, ultrasound, and plasma. Based on advanced multimodal energy platform technology, it has laid out products such as NxPFA, ultrasound RDN, and multimodal tumor ablation systems. It will also further develop overseas registration strategies and global patent layouts based on its current technological leadership advantages, striving to become an international first-class multimodal non-invasive treatment equipment enterprise.
Pulsed electric field ablation (PFA) is a revolutionary ablation method based on high-voltage pulse energy and non thermal irreversible electroporation (IRE) effects. It has technical advantages such as tissue selectivity, non thermal effects, and high efficiency, and is significantly superior to radiofrequency and cryoablation in terms of treatment safety and ablation efficiency. Therefore, PFA is considered an alternative new technology in the field of cardiac electrophysiological ablation.
Maiwei Medical has developed the world's first next-generation pulse electric field cardiac ablation system NxPFA with independent intellectual property rights ®， The third-generation nanosecond pulsed electric field ablation technology (nsPFA) is designed to address the clinical pain points of existing PFA ablation techniques. NxPFA from Maiwei Medical ® The system, based on the team's over 20 years of research on high-voltage pulses and leading domestic all solid state high-voltage pulse core technology, is the world's first PFA cardiac ablation system that can output high repetition rate nanosecond level high-voltage pulses. Through nanosecond pulses, it can optimize the distribution of therapeutic electric fields, reduce muscle contraction, improve surgical safety, and solve the current problems of severe PFA muscle contraction and high anesthesia requirements. It achieves PFA atrial fibrillation ablation surgery only under pain relief, laying a solid foundation for the large-scale clinical promotion and application of PFA technology.

3. Wrist joint prosthesis system: Suzhou Minimally Invasive Joint Medical Technology Co., Ltd
Suzhou Minimally Invasive Joint Medical Technology Co., Ltd. (hereinafter referred to as Minimally Invasive Joint Medical) is a subsidiary of Minimally Invasive Joint Medical ® Orthopedics, focusing on the production and sales of orthopedic joint medical devices and materials, and providing related after-sales services. The company is located in Suzhou Industrial Park, covering an area of more than 5000 square meters, with a 100000 level clean room of 300 square meters, more than 200 employees, including more than 130 professional and technical personnel, and 56 domestic patents. Minimally invasive joint medicine is equipped with precision and highly automated processing and testing equipment, and has strong product research and production capabilities.
minimal invasive ® Orthopedic Group is one of the subsidiary groups of Minimally Invasive Medical Science Co., Ltd. Founded in 2009, after more than ten years of independent research and development and efficient integration of global resources and markets, it has achieved global operation of orthopedic business and become one of the largest orthopedic companies in China. Its orthopedic products are distributed in four major sectors: hip joints, knee joints, spine and trauma. Its product marketing services are available in more than 60 countries and regions, and it has offices in multiple major cities around the world. Minimally Invasive located in Suzhou ® The Orthopedic China Headquarters is an orthopedic innovation industrial park that integrates research and development, manufacturing, logistics, academia, and other functions.

4. Medical carbon dioxide contrast pressure injection kit: Beijing Amet Medical Equipment Co., Ltd
Beijing Amet Medical Equipment Co., Ltd. (hereinafter referred to as Amet) was established in 2011. It is a company that utilizes 3D multi axis precision printing technology for the research and production of fully absorbable coronary stents and peripheral vascular stents. Amet also has fast manufacturing 3D multi axis printing technology for vascular stents and independent intellectual property rights.
This technology is completely different from the laser cutting technology used by foreign companies such as Abbott. It has the characteristics of fast speed, high yield, and good mechanical properties of the product. Therefore, this innovative technology has unparalleled advantages compared to the traditional laser cutting method for manufacturing biodegradable scaffolds. This major breakthrough in scaffold manufacturing technology will enable 3D precision printing technology to go international in China. It will bring revolutionary changes in the manufacturing and use of cardiovascular stents.
In addition, Amet has a professional, innovative, and global talent team composed of experts, professors, PhDs, and masters, and also has an expert committee composed of globally renowned experts and professors. At present, Amet has established close research collaboration relationships with many well-known universities and research institutions at home and abroad.
Amet has strong technological innovation and product development capabilities. Undertook projects supported by the 13th Five Year Plan of the Ministry of Science and Technology, the strategic emerging industry cultivation project of the Beijing Science and Technology Commission, and the innovation project for small and medium-sized enterprises in Haidian Park of Zhongguancun Management Committee. Amet will rely on its core 3D precision printing technology platform to continuously expand its application areas, committed to researching and producing high-performance intravascular implantation and intervention products, and building Amet into an internationally excellent medical device company.

5. Interventional left ventricular assist system: Abiomed Corporation
Abiomed, founded in 1981 and headquartered in Massachusetts, USA, is a leading provider of medical devices that provide circulatory support and oxygenation. It is also a global leader in the field of ventricular assist blood pumps (VADs). Its Impella heart pump is the only percutaneous heart pump technology approved by the US FDA for patients with severe coronary artery disease such as high-risk PCI or AMI cardiogenic shock.
In December 2022, Abiomed was acquired by Johnson&Johnson for $16.6 billion to consolidate Johnson&Johnson's cardiovascular equipment business. Currently, Abiomed operates independently as part of Johnson&Johnson's Medical Technology division.
The Impella device (Abiomed) is an intravascular microaxis blood pump that provides temporary MCS to patients, reducing cardiac workload and improving systemic circulation. The Impella device is used during HRPCI or for the treatment of cardiogenic shock, cardiomyopathy, and severe myocarditis after acute myocardial infarction or cardiac surgery.
The left Impella device is a microaxis pump located at the entrance of the aortic valve into the left ventricle (LV), providing continuous anterograde blood flow from the left ventricle to the ascending aorta, thereby reducing the workload of the left ventricle and increasing cardiac output. The result is to improve systemic perfusion, increase coronary artery blood flow, and reduce myocardial oxygen demand. The right device transports blood from the entrance area of the inferior vena cava to the pulmonary artery.

6. Disposable heart pulse electric field ablation catheter: Shanghai Minimally Invasive Electrophysiological Medical Technology Co., Ltd
Shanghai Minimally Invasive Electrophysiology Medical Technology Co., Ltd. (hereinafter referred to as "Minimally Invasive Electrophysiology") was established on August 31, 2010 in Shanghai International Medical Park and listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange on August 31, 2022. Minimally invasive electrophysiology is a high-tech enterprise dedicated to the research and development, production, and sales of innovative medical devices in the fields of electrophysiological intervention diagnosis, treatment, and ablation therapy. It is committed to providing globally competitive "diagnostic and ablation therapy integrated solutions with precision intervention navigation as the core".
In order to meet the treatment needs of patients with rapid arrhythmia, minimally invasive electrophysiology has always adhered to innovation and breakthroughs in core technologies since its establishment. After more than ten years of continuous innovation, minimally invasive electrophysiology has completed a comprehensive product layout covering cardiac electrophysiology surgery. It is the first domestic manufacturer to provide a complete solution for three-dimensional cardiac electrophysiology equipment and consumables, and has achieved a collaborative layout of "radiofrequency+cryotherapy" two mainstream ablation energy products.
The first generation Columbus 3D cardiac electrophysiological mapping system independently developed by Minimally Invasive Electrophysiology entered the special approval process for innovative medical devices in 2015 and was approved for market by the National Medical Products Administration in 2016. At the same time, five innovative products of minimally invasive electrophysiology have entered the national special approval process for innovative medical devices (green channel), including Columbus 3D cardiac electrophysiological mapping system, FireMagic cold saline infusion radiofrequency ablation catheter, Flashpoint renal artery radiofrequency ablation catheter, FireMagic pressure sensing magnetic positioning infusion radiofrequency ablation catheter, and IceMagic cardiac cryoablation system.
The Columbus 3D cardiac electrophysiological mapping system is mainly used for the diagnosis and treatment of complex arrhythmia diseases. The system can use the information obtained from magnetic field positioning to establish a 3D heart chamber model, and integrate the electrocardiogram signals recorded by the catheter in various parts of the heart chamber on the dissection site of the model. By combining intracardiac electroencephalography with spatial structures, it helps patients complete ablation therapy for complex arrhythmias.

7. Puncture surgery navigation and positioning system: Hangzhou Weiyin Technology Co., Ltd
Hangzhou Weiyin Technology Co., Ltd. (hereinafter referred to as Weiyin Technology) was established in June 2020. The founding team has long served well-known medical and research institutions such as GE, Mayo Clinic, and Philips Medical in the United States. It is a leading platform company for holographic diagnostic and surgical robots in the industry. Weiyin Technology focuses on empowering medical imaging equipment with automation, intelligence, and platformization capabilities. It is one of the few robot companies in the world with comprehensive medical imaging guidance capabilities such as CT, ultrasound, and magnetic resonance imaging.
The MicroIGT RoboU, developed by Weiyin Technology, is capable of fully automated and unmanned screening of carotid artery plaques. It is the world's first fully automated carotid artery ultrasound scanning robot. This product uses an ultrasound diagnostic system combined with an original self-developed 7-axis degree of freedom robotic arm to clamp the ultrasound probe for multi degree of freedom movement. Through force tactile feedback algorithm, the ultrasound probe is flexibly attached to the human neck to achieve carotid artery scanning. The robotic arm has currently obtained CE certification.
The robot contains an AI algorithm engine and uses multiple deep learning models to train on tens of thousands of ultrasound imaging data from public data, partner hospitals, doctor groups, etc. It can identify various organs in the neck like a doctor and judge lesions such as carotid plaques, stenosis, and occlusion. After the scan is completed, the system generates an AI lesion risk alert and automatically generates a complete report.

Source: https://news.yaozh.com/archive/44400.html