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

Recently, the National Medical Products Administration approved the registration application for an innovative product by Brainsight Medical Technology (Shanghai) Co., Ltd., an implantable brain-computer interface hand movement functional compensation system, achieving the world’s first launch of a brain-computer interface medical device. This marks that the world’s first invasive brain-computer interface medical device has entered the clinical application stage. The product consists of a brain-computer interface implant, an implantable electroencephalogram (EEG) electrode kit, an EEG signal transmitter and receiver, pneumatic glove equipment, a disposable surgical instrument kit, EEG decoding software, medical testing software, and clinical management software. It is suitable for patients with quadriplegia caused by cervical spinal cord injury, and enables hand grasping function compensation assisted by pneumatic glove equipment. Patients must meet the following conditions: aged 18 to 60; quadriplegia with cervical spinal cord injury from C2 to C6 rated A to C; the disease diagnosed for more than 1 year and, after standardized treatment, a stable condition for at least 6 months; unable to complete grasping with the hands, but with some residual function in the upper arm. The product uses minimally invasive extradural implantation and wireless energy supply communication technology. Clinical trial results show that, through this product, subjects achieved a significant improvement in hand grasping ability, thereby improving patients’ quality of life. (CCTV News)