NextFin News -- China's National Medical Products Administration has approved the innovative product registration application for the implanted brain-computer interface hand motor function compensation system developed by Neuracle Medical Technology (Shanghai) Co., Ltd.
This marks the debut of the world's first invasive brain-computer interface medical devices and BCI's entry into the clinical adoption phase.
The product consists of a brain-computer interface implant, an implanted electroencephalogram (EEG) electrode kit, an EEG signal transceiver, a pneumatic glove device, a disposable surgical toolkit, EEG decoding software, medical testing software, and clinical management software. It is designed for patients with quadriplegia caused by cervical spinal cord injuries. The pneumatic glove device assists in compensating for hand gripping functions.
To be eligible, patients must meet the following criteria: aged between 18 and 60, classified with cervical spinal cord injuries (C2-C6) rated A-C, diagnosed with the condition for over one year, and stable for at least six months following standardized treatment, with an inability to grip using their hands but retaining some upper arm function. The product employs invasive extradural implantation and wireless power communication technology. Clinical trial results indicate that participants have demonstrated a significant improvement in hand gripping ability through the use of this product, thereby enhancing the quality of life for patients.
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