The first invasive brain-machine interface medical device approved for market.

Recently, the National Medical Products Administration approved the registration application for the innovative product of implanted brain-machine interface hand movement function compensation system developed by Borecon Medical Technology Co., Ltd., marking the global first launch of brain-machine interface medical devices and signaling the entry of the world's first invasive brain-machine interface medical device into clinical applications. The product consists of brain-machine interface implants, implanted brain EEG electrode kits, EEG signal transceivers, pneumatic glove devices, disposable surgical tool kits, brain EEG decoding software, medical testing software, and clinical management software. It is suitable for patients with quadriplegia due to cervical spinal cord injury, assisting in compensating for hand grip function through pneumatic glove devices. Patients must meet the following criteria: 18 to 60 years old, quadriplegia ranging from C2 to C6 cervical spinal cord injury with grades A to C, disease diagnosed for more than 1 year and stabilized for at least 6 months after standard treatment, inability to grip with the hands, and partially functional upper arms. The product utilizes minimally invasive implantation with wireless power transmission technology outside the dura mater. Clinical trial results have shown that subjects achieved a noticeable improvement in hand grip ability, leading to an improvement in the quality of life of patients.