BRAINAURORA-B (06681.HK): Depression Cognitive Assessment Software Wins Class II Device Registration

NewTimeSpace News: On 27 October 2026, BrainAurora Medical Technology Limited (stock code: 6681) published a voluntary announcement that it received, in the evening of 27 October 2026, a Class II medical device registration certificate issued by the Beijing Municipal Medical Products Administration for a cognitive function assessment software product for patients with depression.

The product, model BJHZ-NACT, is standalone software that assesses four dimensions—memory, attention, executive function and information processing speed—and produces results to help clinicians understand patients' cognitive status and support subsequent treatment. Its clinical trial began in September 2024 and was completed in August 2025.

Cognitive symptoms persist throughout the course of depression, affecting the response and cure rates of antidepressant treatment, increasing relapse risk and preventing some patients from returning to normal social functioning, the announcement said. The certificate is the Company's first medical device registration from the Beijing authority and the first cognitive function assessment device registration in the depression field, which the Company said marks a regulatory breakthrough and an early-mover position and completes its digital cognitive healthcare portfolio. The Company cautioned that it may ultimately fail to commercialise and sell the product.