en.Wedoany.com Reported - Recently, the "second-level rotation speed coaxial coplanar diagnostic CT-guided medical electron linear accelerator" independently developed by CNNC Particle, a subsidiary of China National Nuclear Corporation (CNNC), has successfully entered the National Innovative Medical Device Special Review Procedure of the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration. This marks a critical step for CNNC on the path to self-reliance in high-end radiotherapy equipment, and lays a solid foundation for accelerating product market launch and early clinical application.
As China's first product of its kind to enter this review procedure, the second-level rotation speed coaxial coplanar diagnostic CT-guided medical electron linear accelerator achieves an integrated design combining the electron linear accelerator and fan-beam CT in a single gantry with coplanar configuration. It enables simultaneous acquisition of diagnostic-grade CT images and precise positioning guidance in the treatment position, leveraging high-definition onboard imaging and an intelligent operating system to optimize the entire process from precise positioning to efficient treatment.
The "Innovative Medical Device Special Review Procedure" is a special mechanism established by the National Medical Products Administration to encourage the development of original medical devices and promote the rapid clinical application of new technologies. Entry into this review procedure signifies that the product's technological leadership and significant clinical value have been recognized by the national authoritative review body.
As CNNC's market-oriented independent innovation platform for nuclear medical equipment, CNNC Particle is committed to building an autonomous and controllable high-end radiotherapy ecosystem. It has established three major product lines: medical electron linear accelerators (LINAC), SPECT/CT integrated systems, and boron neutron capture therapy (BNCT) equipment. The coaxial coplanar diagnostic CT-guided medical electron linear accelerator currently under review is a key achievement of this strategic layout. At present, CNNC Particle is efficiently advancing the product registration process for the medical linear accelerator to ensure its safe and effective performance for clinical application as soon as possible.
