Five Innovative Medical Devices Enter China's Fast-Track Review Channel

On June 30, 2026, the National Medical Products Administration announcedPublic Notice of Review Results for Applications for Special Review of Innovative Medical Devices (No. 11, 2026), there is5 ProductsEnter the Innovation Pathway.

1. Product Name: Vascular Graft

Applicant: CAREVITA

CAREVITAEstablished in 2021, it is a company listed on the ChiNext Board.Jiangxi Sanxin Medtec Co., Ltd. (300453.SZ)a wholly-owned second-tier subsidiary. The company focuses on the research and development and production of extracorporeal circulation and blood processing equipment, as well as medical polymer materials and products, and obtained in March 2024Medical Device Production License。

Its core productsCoreVascu Artificial Blood VesselFeaturing an integrated ePTFE design, the nationwide multicenter clinical trial was launched in 2025, with the first clinical implantation completed.Aimed atBreaking the Long-Standing Monopoly of Foreign Giants on Artificial Blood Vesselsthe situation of,Providing Domestic Vascular Access Solutions for Hemodialysis Patientscase. Its parent company, Sanxin Medical, has been deeply engaged in the field of blood purification for over two decades, possessingNational High-Tech Enterprise, Academician Workstationand other innovative platforms.

2. Product Name: Ophthalmic Surgical Assistance System

Applicant: Guangzhou Oculotronics Medical Instrument Co., Ltd.

Guangzhou Oculotronics Medical Instrument Co., Ltd.Established in December 2020, it is a company focused onOphthalmic Microsurgical Robota high-tech enterprise engaged in research and development. The company independently develops originalSerial-Parallel Surgical Robot Technology System, with repeat positioning accuracy stably controlled atBelow 10 μm, effectively filtering out physiological hand tremors.

Core ProductsCleaved^®High-Precision Ophthalmic Surgical RobotSuitable for a variety of high-difficulty ophthalmic surgeries, including vitreoretinal surgery, intravitreal injection, and corneal transplantation.In 2025, the company completedWorld's First 5G Remote Micron-Level Ophthalmic Surgery; Completed in June 2026Series A Financing of Nearly RMB 100 Million, Concluded SimultaneouslyChina's First Multicenter Randomized Controlled Registration Clinical Trial for Ophthalmic Surgical RobotsThe company has established three major product systems: fundus surgery systems, precision drug delivery systems, and ophthalmic training systems.

3. Product Name: Digestive System DNA Fragment Characteristic Detection Kit (Joint Probe Anchored Polymerization Sequencing Method)

Applicant: Geneseeq Medical Device and Diagnostic Inc

Geneseeq Medical Device and Diagnostic IncEstablished in 2015, it is a wholly-owned subsidiary of Nanjing Geneseeq Biotechnology Co., Ltd., primarily engaged in the research and development, manufacturing, and sales of in vitro diagnostic reagents and supporting equipment, with significant advantages in the field of tumor next-generation sequencing (NGS) diagnostics.

Core products include the Tissue TMB Test Kit for Non-Small Cell Lung Cancer, the EGFR/ALK/ROS1/BRAF/KRAS/HER2 Gene Mutation Detection Kit (Yishengkang™), and the Pan-Cancer 425-Gene NGS Detection Kit. The company also provides personalized guidance on tumor medication, monitoring of drug-resistance mutations, and customized IVD product services.

4. Product Name: Puncture Surgery Navigation and Positioning System

Applicant: Beijing Yiru Jingzhi Medical Technology Co., Ltd.

Beijing Yiru Jingzhi Medical Technology Co., Ltd.Established in March 2024 and located in Haidian District, Beijing, it is a company founded byClinical Experts and Experts in Surgical Robotics and Artificial Intelligence TechnologiesA co-founded medical technology enterprise. The company focuses on the research and development of intelligent surgical equipment, optimizing surgical procedures through surgical robots and artificial intelligence technology.Core directions includeNavigation and Positioning for Puncture Proceduresetc. The company has applied for patents related to endoscopic control systems and surgical operation devices, committed to promoting the advancement of surgical procedures towardIntelligent, Precisiondirection.

5. Product Name: Abdominal Aortic Stent Graft System

Applicant: Lombard Medical Co., Ltd.

Lombard Medical Ltd.is an international enterprise focused on the research and development of vascular interventional devices.The company entity, Lombard Medical Limited, was founded in 1994 and is headquartered in Didcot, Oxfordshire, UK; it established a wholly-owned sales subsidiary, Lombard Medical Technologies GmbH, in Germany to cover the continental European market. Deeply engagedThoracic/Abdominal Aortic Aneurysm Endovascular Stent Graft System, addressing the clinical pain points of traditional open surgery—namely, its high invasiveness and the lack of suitable devices for patients with complex aneurysm necks. The product portfolio covers the full spectrum of scenarios, including endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms, thoracic endovascular aortic repair (TEVAR) for thoracic aortic aneurysms, and post-operative repair and revision.