Zhongji Flash e-Flash 200A Enters Innovative Medical Device Special Review Program

Recently, the public notice period for the review results of applications for the Innovative Medical Device Special Review Program by the Center for Medical Device Evaluation of the National Medical Products Administration has concluded. The ultra-high dose rate electron beam radiotherapy system (e-Flash 200A), independently developed by Zhongji Flash Medical Technology Co., Ltd., has officially entered the Innovative Medical Device Special Review Program.

According to reports, the e-Flash 200A is China's first ultra-high dose rate electron beam FLASH radiotherapy device and had previously been included in the "Global New" green channel. Its entry into the Innovative Medical Device Special Review Program signifies further recognition of the product's technological innovation and clinical application value.

The system is designed for application scenarios such as superficial tumor radiotherapy and scar removal. Leveraging millisecond-level ultra-high dose rate electron beam irradiation technology, it can deliver radiation to the lesion within an extremely short time. According to the company, the device can rapidly destroy tumor cell DNA while minimizing damage to normal tissues, reducing a single treatment session to less than one second. It is expected to compress the original radiotherapy course of approximately one month into just a few sessions or even a single treatment, thereby improving the patient treatment experience.

Zhongji Flash stated that, as the next step, it will continue to advance the clinical trials and registration and market launch of the e-Flash system in accordance with the requirements of the national drug regulatory authorities, striving to facilitate the device's entry into clinical application as soon as possible.