Multiple Chinese-Made Medical Devices Gain FDA Clearance in 2026, Highlighting Rising Innovation Capabilities

　　【Pharmaceutical Network | Industry Trends] Recently, MicroPort NeuroTech announced that its subsidiary, MicroPort NeuroVascular, has independently developed the NUMEN™ Helia Coil Embolization System (NUMEN™ Helia), which has officially received marketing approval from the U.S. Food and Drug Administration (FDA). According to available information, NUMEN™ Helia is indicated for the occlusion or obliteration of neurovascular abnormalities via an endovascular approach to interrupt blood flow. Compared with other previously marketed products in the NUMEN series, NUMEN™ Helia features the core advantages of being “longer, thinner, and softer.”
 

It is reported that this approval marks the third coil product launched by the Group in the U.S. market, following the NUMEN detachable coils and the NUMEN Silk 3D electrolytic detachable coils. In addition to these products, the APOLLO Dream®/Apollo™ Dream Intracranial Aneurysm Rapamycin-Targeted Eluting Stent System, developed by MicroPort NeuroTech under the Group, also received Breakthrough Device Designation from the U.S. FDA in March.
 

This system integrates targeted drug-eluting technology with an optimized stent mechanical structure. While providing stable vascular support and restoring blood flow patency, it achieves targeted release of sirolimus to the vessel wall to inhibit vascular smooth muscle cell proliferation, thereby reducing the risk of post-procedural restenosis.
 

Industry analysts believe that the FDA approval of multiple products from Minimally Invasive Brain Science not only demonstrates the company's continuous breakthroughs in the research and development of innovative neurointerventional products and international registration but also reflects the growing competitiveness of Chinese medical devices in the high-end, innovative medical device sector.
 

It is reported that since 2026, multiple domestically produced medical devices have received FDA approval or clearance, covering high-end surgical consumables, innovative diagnostic equipment, and cutting-edge therapeutic devices. For instance, in April, BrioHealth Solutions announced that its wholly-owned subsidiary in the United States had obtained conditional approval from the U.S. FDA to initiate the clinical evaluation of the BrioVAD® system for pediatric patients with advanced heart failure—the Brio4Kids clinical trial.
 

It is reported that the Brio4Kids clinical trial is a prospective, multicenter, single-arm clinical study scheduled to be conducted jointly at seven pediatric cardiac centers in the United States and two centers in Japan, with a planned enrollment of 25 to 65 patients. Subject enrollment for the U.S. clinical trial is expected to commence in mid-2026, with preliminary data anticipated in the fourth quarter.
 

In March, DCwire, a micro-guidewire independently designed and developed by Achieva, a subsidiary of Peijia Medical, officially received FDA 510(k) clearance in the United States. It is understood that the certified DCwire is a neurointerventional micro-guidewire based on a “micro-structure” design. The product features excellent performance, including precise maneuverability and ease of superselective catheterization, enabling clinicians to rapidly and conveniently establish surgical access during procedures.
 

In February, Eieling Technology Limited officially announced that its FattaLab hepatic fat measurement device had received FDA 510(k) clearance in the United States. FattaLab® focuses on addressing the critical needs of early screening and long-term management of fatty liver disease. By employing the patented AutoIntra‑FocusFusion algorithm for hepatic fat detection, combined with automatic region-of-interest (ROI) adjustment technology, the device effectively excludes interference from non-hepatic tissues and delivers quantitative results within 30 seconds. Notably, FattaLab® had previously won the Innovation Award at the 2026 Consumer Electronics Show (CES), organized by the Consumer Technology Association.
 

Overall, since 2026, Chinese medical device manufacturers have achieved several key milestones in FDA registration and approval in the United States. These advancements will lay a solid foundation for high-end Chinese medical devices to occupy a more prominent position in the international market in the future.
 

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