Recently, the innovative product "Neurosurgical Planning Software" of Sinovation (Beijing) Medical Technology Co., Ltd. is approved by China NMPA. This marks the 300th innovative medical device to receive approval.

This product consists of software installation programs and authorization files. The software function module includes: user login, patient sequence management, surgical planning, image registration, 3D reconstruction, stereotactic frame parameter calculation, and fiber tract generation. It is designed to develop neurosurgical planning.

This product employs multi-dimensional spatial vascular reconstruction and avoidance technology, which enables the optimization of surgical paths and improves clinical efficiency by combining existing head frame tools and planning paths. This technology is at the forefront of international standards and is pioneering in its field.

Innovative medical devices represent a new quality productive force in the medical device sector. In recent years, the NMPA has deepened reforms in the review and approval system for medical devices, addressing “blockages” and “difficulties” in the development of the medical device industry. The NMPA has continuously improved mechanisms to support the development of innovative medical devices, particularly focusing on areas such as medical robotics, artificial intelligence, medical imaging, and biomaterials, targeted research support initiatives, while strengthening inter-departmental cooperation to accelerate the listing and application of innovative products to better meet the public's demand for medical devices.

Moving forward, the NMPA will thoroughly implement the spirit of the Third Plenary Session of the 20th Central Committee of the Communist Party of China, focusing on the primary task of promoting high-quality development. The NMPA will implement the reform measures proposed in the Resolution of CPC Central Committee on Further Deepening Reform Comprehensively to Advance Chinese Modernization, advance the legislation of medical device management laws, and continue to provide enhanced support and guidance for the research and development of innovative medical devices. More resources will be allocated to the review and approval processes, ensuring that the benefits of medical device sector reforms are more equitably shared among the people.