Medtronic, Mindray Among 14 Companies Granted Fast-Track Review for Innovative Medical Devices in China

On July 2, 2025, the NMPA announced the public notice of the review results for the special review application of innovative medical devices (No. 6 of 2025), with 14 products entering the innovation channel.

1. Product Name: Breast Ultrasound Auxiliary Assessment Software

Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Mindray Medical was founded in 1991, with its headquarters located in Shenzhen, China. It is a global leading supplier of medical equipment. The company was established by seven former employees of Anke Biotech, including Li Xiting and Xu Hang. Its business covers patient monitoring and life support, in-vitro diagnostic products, and medical imaging systems. Mindray has 41 subsidiaries across 31 countries, with global R&D centers distributed in locations such as Shenzhen, Wuhan, Nanjing, and Silicon Valley in the United States, employing 4,897 R&D engineers.

In 2024, the company's annual operating revenue was 36.73 billion yuan, a year-on-year increase of 5.1%. The net profit attributable to parent company was 11.67 billion yuan, a year-on-year increase of 0.7%. After excluding the impact of financial expenses, the net profit attributable to parent company increased by 4.4% year-on-year. The net operating cash flow was 12.43 billion yuan, a year-on-year increase of 12.4%.

2. Product Name: Posterior Chamber Phakic Refractive Correction Intraocular Lens

Applicant: Wuxi Vision Pro Ltd.

Wuxi Vision Pro Ltd. (referred to as Vision Pro) was established in 2010. It is a technology enterprise specializing in the research, production, and sales of high-end ophthalmic consumables such as intraocular lenses. The company is committed to breaking through the technical R&D bottlenecks and key industrialization technologies of foldable intraocular lenses in China, creating a series of mid-to-high-end intraocular lens products with internationally advanced technical levels.

Vision Pro has strong research and development capabilities, with a highly educated R&D team led by several PhDs. In collaboration with scientific research institutions and clinical hospitals in China, it has successfully developed a new generation of hydrophobic acrylic material and a series of intraocular lens products. The technical performance of these products has reached an internationally advanced level. Clinical trial results of the RS Series intraocular lenses showed that "all indicators of Vision Pro’s intraocular lenses are similar to those of imported counterparts, demonstrating excellent efficacy in improving visual function."

Vision Pro has introduced internationally advanced production equipment, and its production line has obtained ISO-13485 quality management system certification. Its self-developed series of hydrophobic acrylic intraocular lenses - MS spherical, RS aspherical, and TS toric (astigmatism-correcting) intraocular lenses - have obtained EU CE certification. Among them, the RS series and MS series have been approved for marketing by the China CFDA.

3. Product Name: Head Gamma Ray Stereotactic Radiosurgery Treatment System

Applicant: Shenzhen Dayi Gamma Knife Technology Co., Ltd.

Shenzhen Dayi Gamma Knife Technology Co., Ltd., since its establishment in 1993, has been committed to the development and innovation in the field of medical technology. Headquartered in Pingshan District, Shenzhen, the company focuses on the research, production, and sales of high-end medical devices, particularly possessing deep technical expertise in the field of radiotherapy equipment such as Gamma Knife. Integrating R&D, production, sales, and service, the company's product range covers Class I, II, and III medical devices, widely used in medical fields such as cancer treatment.

4. Product Name: Brachytherapy Planning Software

Applicant: Suzhou Puneng Medical Technology Co., Ltd.

Suzhou Puneng Medical Technology Co., Ltd. was established in May 2020. It is a national high-tech enterprise specializing in the research, development, production, and services of products related to brachytherapy for cancer treatment.

The founding team of the company has rich experience in the field of tumor radiotherapy and possesses strong independent research and development capabilities, achieving a series of innovative results with independent intellectual property rights. The company adheres to the development philosophy and goal of "focusing on cutting-edge technology and promoting precision medicine," continuously exploring the frontiers of brachytherapy technology, and is dedicated to the research and development of composite-guided adaptive brachytherapy system products. It has obtained a medical device production license and four medical device product registration certificates.

5. Product Name: Sinusoidal Posterior Chamber Refractive Intraocular Lens

Applicant: Hangzhou Aijinglun Technology Co., Ltd.

Hangzhou Aijielun Technology Co., Ltd. was established in 2015, with its headquarters and production-research base located in Yuhang District, Hangzhou. It is an innovative ophthalmic medical device enterprise integrating research, production, sales, and service.

Hangzhou Aijinglun's independently intellectual property-owned suspended artificial lens, Yijing PRL, was first approved for marketing by the CFDA in 2009 and obtained renewal registration on October 31, 2019. This product is not only a domestically produced phakic posterior chamber refractive lens in China but also the only suspended product in China. The Yijing PRL corrects a range of 1000 to 3000 degrees, filling the international correction gap between 1800 and 3000 degrees.

In April 2020, Haohai Bio acquired 55% equity of Hangzhou Aijielun, incorporating the PRL lens into its ophthalmic product portfolio to expand the refractive surgery market.

6. Product Name: Biodegradable Zinc Alloy Interface Screw

Applicant: Beijing Shangning Kezhi Medical Device Co., Ltd.

Beijing Shangning Kezhi Medical Device Co., Ltd. is an innovative biomedical device company with a core focus on the research and application of medical metal materials. The company specializes in the comprehensive application of biodegradable zinc alloy technology in the human body environment. Recognized as a "National High-tech Enterprise," its research team has undertaken multiple projects from the Ministry of Science and Technology and the National Natural Science Foundation of China. The company's biodegradable zinc alloy technology for medical use has been awarded the Second Prize of the National Science and Technology Progress Award. With a diverse product portfolio, several products have completed development and finalization. Among them, orthopedic products have entered clinical trials, while gynecological, dental, and pediatric products are progressing steadily.

In March 2024, the company's independently developed and produced degradable zinc alloy interface screws and zinc plates with loops completed the enrollment of the last patient. Beginning from the first clinical enrollment in June 2023, in less than a year, the patient enrollment for the clinical study on the "Safety and Effectiveness of Degradable Zinc Alloy Interface Screws and Zinc Plates with Loops in Anterior Cruciate Ligament Reconstruction" was successfully concluded.

7. Product Name: Electrophysiology 3D Navigation Radiofrequency Pulse Ablation System

Applicant: Medtronic

Medtronic (NYSE: MDT), founded in 1949 and headquartered in Minneapolis, Minnesota, USA, is a global leading medical technology company with over 95,000 employees.

Medtronic's innovative solutions have expanded to more than 70 key disease areas, committed to providing lifelong treatment options for patients with chronic conditions. Every second, two patients around the world benefit from Medtronic's medical technologies or therapies.

8. Product Name: Dental Implant Retractor

Applicant: Shanghai Yangshan Biotechnology Co., Ltd.

Shanghai Yangshan Biotechnology Co., Ltd. was established in September 2023 and is located in Minhang District, Shanghai. The company has established cooperative relationships with top-tier tertiary hospitals in China and several well-known chain dental clinic groups. Additionally, the company's core product has won the National Science and Technology Progress Award, and the core team members are all senior professionals in the fields of surgical robotics and oral-maxillofacial equipment.

9. Product Name: Disposable Electric Hemorrhoid Stapler with Absorbable Staples

Applicant: Aesculap (Xiamen) Medical Devices Co., Ltd.

Shiaide (Xiamen) Medical Equipment Co., Ltd. (hereinafter referred to as "Shiaide Medical") was established in 2010 and is under the Dabo Medical (Stock Code: 002901). It is a professional medical device company engaged in the research, development, production, and sales of surgical medical devices.

Since its establishment, Shi Aide Medical has placed high importance on talent cultivation, consistently adhered to independent research and development, and created numerous innovative surgical products with high technical content and excellent added value, successfully obtaining 110 invention patents. Committed to technological innovation, the company has established long-term stable industry-academia-research cooperation relationships with more than ten universities and research institutions both in China and abroad.

Relying on the strong manufacturing capabilities of its headquarters, ShiAide Medical is equipped with advanced production equipment from the United States, Japan, Germany, and Switzerland. It has built a digital management platform that integrates design, technology, manufacturing, and quality control, and has successfully passed the ISO13485 and CE certifications as well as on-site inspections.

Guided by clinical needs, Ideal Medical has developed a diversified range of surgical instrument product lines, covering access systems, staplers, ligation devices, ultrasonic scalpels, insufflators, artificial intelligence, and more. With dedicated efforts, the company's access system products have achieved a market coverage rate ranking among the top three in China for similar products, and are exported to over 10 countries and regions including South Korea, Chile, and the Netherlands, continuously gaining attention and recognition from both domestic and international markets.

10. Product Name: Pulsed Electric Field Ablation System

Applicant: Heart Navigation Road Medical Technology (Guangzhou) Co., Ltd.

Mind Voyage Medical was founded in May 2020 by senior electrophysiology experts from China and the United States. Headquartered in Guangzhou, China, the company has established a wholly-owned subsidiary in California, USA.

DePolar Mapping System, independently developed by Xinhang Road Medicine, is the world's first "four-dimensional" cardiac mapping system. The DePolar Mapping System seamlessly integrates magnetic and electrical contact-based mapping with non-contact magnetic and electrical mapping in both technical development and clinical application, forming a unified mapping architecture.

Relying on the DePolar mapping system, Cardionav Medical has developed an integrated 3D PFA product portfolio of "magnetic and electric 3D + magnetic and electric PFA," proactively deploying a variety of globally innovative PFA ablation catheters. It is suitable for the comprehensive treatment of complex arrhythmias such as paroxysmal atrial fibrillation and atrial flutter, and will be the world's only PFA product portfolio capable of mapping persistent atrial fibrillation and achieving personalized ablation.

The company's pioneering "5D Cardiac Electro-mapping Technology" integrates three-dimensional spatial positioning with the "depolarization-repolarization" time axis, enabling real-time dynamic visualization of atrial fibrillation mechanisms and significantly improving the precision and success rate of catheter ablation.

11. Product Name: Biodegradable Atrial Septal Defect Occluder

Applicant: Shanghai Jinkui Medical Device Co., Ltd.

Shanghai Jinkui Medical Device Co., Ltd. ("Jinkui Medical" for short) was established in 2003 and is a high-tech innovative enterprise specializing in the research, production, and sales of high-value cardiovascular interventional devices. The single-flange atrial septal defect occluder and single-flange patent ductus arteriosus occluder currently on sale are both domestic firsts in China, further improving the clinical treatment outcomes for patients with structural heart diseases. The company has formed partnerships with multiple clinical trial bases and research institutions within China to actively promote an integrated development mechanism for industry, academia, and research.

Jin Kui Medical has now passed the ISO13485 quality system certification and GMP certification, owns nearly 80 invention patents, and undertakes several National Natural Science Foundation projects as well as provincial and municipal Science and Technology Commission projects.

12. Product Name: Boron Neutron Capture Therapy System

Applicant: Guoke Neutron Medical Technology Co., Ltd.

China Neutron Medical Technology Co., Ltd. (referred to as: China Neutron) was established in 2021, located in Songshan Lake, Dongguan, China. It is a high-tech enterprise specializing in the research, development, production, and market promotion of high-end medical equipment for accelerator boron neutron capture therapy (BNCT). The company was jointly founded by CAS Holdings Co., Ltd., the Institute of High Energy Physics of the Chinese Academy of Sciences, and Dongguan Songshan Lake Science City.

On March 21, 2025, the delivery ceremony of the inspection report for the clinical Boron Neutron Capture Therapy (BNCT) equipment of Guoke Neutron Medical Technology Co., Ltd. was grandly held at Dongguan People's Hospital. This marks that China's first clinical BNCT device with complete independent intellectual property rights has successfully passed the Class III medical device inspection.

13. Product Name: Absorbable Isolation Hydrogel

Applicant: Shanghai Rui Ning Biotechnology Co., Ltd.

Shanghai Rui Ning Biotechnology Co., Ltd. (referred to as "Rui Ning Bio") was established in 2018. It is a "specialized, refined, distinctive, and innovative" enterprise in Shanghai, focusing on the research and development and industrialization of high-end biomedical materials. The founding team of Rui Ning Bio originates from top biotechnology material laboratories in both China and the US. The company has established in-depth industry-university-research cooperation with China's leading cancer treatment centers, effectively promoting the application of next-generation innovative biomaterial technologies in clinical and medical fields, with comprehensive talent and technical reserves.

Currently, Raynove Bio has built a globally leading medical hydrogel technology platform, and based on this platform, developed several domestically pioneering Class III implantable/interventional medical devices, with a rich and comprehensive product pipeline. In addition to the cervical cancer radiotherapy protective isolation hydrogel that has completed registered clinical trials, the products also include tumor embolic hydrogels, intrauterine anti-adhesion hydrogels, and more.

14. Product Name: Transcatheter Intramyocardial Radiofrequency Ablation System for Ventricular Septum

Applicant: Suzhou Sainasi Medical Technology Co., Ltd.

Suzhou SinoMed Medical Technology Co., Ltd. was established in 2017 as an innovative medical technology company specializing in the field of cardiac electrophysiology. The company is committed to providing research, production, and sales of innovative medical devices for the cardiac electrophysiology sector, adhering to the concept of "safe and effective, simple and accessible" to offer innovative solutions for global healthcare. The company’s product portfolio includes both active and passive electrophysiology products, such as ventricular septal ablation systems, pulsed ablation systems, atrial septal puncture needles/sheaths, stabilizers, and vascular knives.