Zhitong Finance App News, Brain Action Aurora-B (06681) issued an announcement. The company received a Class II medical device registration certificate for cognitive function assessment software for patients with depression issued by the Beijing Drug Administration (Beijing Administration) on the evening of October 27, 2026. The relevant information is now announced as follows:
This product is cognitive function assessment software. The specification model is BJHZ-NACT, and the registration category is a Class II medical device. The registration certificate was issued by the Beijing Bureau. The registration certificate number: Beijing Equipment Note 20262210410. The company received it on the evening of October 27, 2026. This product is an independent software for evaluating cognitive function in patients with depression. It evaluates and issues results around the four dimensions of memory, attention, executive function, and information processing speed, making it easy for clinicians to understand patients' cognitive status and providing safe and effective evidence for subsequent treatment. Clinical trials of this product began in September 2024 and completed in August 2025.
Cognitive symptoms persist throughout the course of depression, affecting the effectiveness and cure rate of antidepressants, increasing the risk of recurrence, and causing some patients to be unable to resume normal social function, causing a huge social and economic burden.
This product is the first medical device registration certificate obtained by the Beijing Bureau. It is also the first medical device registration certificate for cognitive function assessment in the field of depression. It marks the company's breakthrough registration in the field of cognitive assessment of mental illness, occupied a leading position in the market, and further improved the company's digital medical product layout for cognitive impairment. The board of directors believes that the above registration results will help strengthen the Group's position in the digital medical field for cognitive impairment and conform to the overall interests of the Group and shareholders.