Core Viewpoint - The article highlights a significant breakthrough in the brain-computer interface (BCI) field with the approval of the NEO device in China, marking the first BCI treatment device to move from clinical trials to broader application globally [3][12]. Group 1: Product Overview - The NEO device, developed by Neuracle Medical Technology in collaboration with Tsinghua University, is designed for patients aged 18 to 60 who suffer from quadriplegia due to cervical spinal cord injuries, aiming to restore hand movement functionality [3][10]. - NEO is a coin-sized device implanted through minimally invasive surgery, featuring eight electrodes that attach to the surface of the brain, allowing patients to control a soft robotic glove through thought [5][9]. Group 2: Clinical Evidence - Clinical data over 18 months demonstrates the safety and efficacy of NEO, which is rare in the BCI field [3]. - A study published by Tsinghua University and other institutions showed significant improvement in hand functions for a patient with complete spinal cord injury after using NEO for nine months, enabling independent eating and drinking [7][9]. Group 3: Competitive Advantage - NEO's non-invasive nature, with electrodes placed on the brain's surface rather than inserted into brain tissue, is a key factor in its rapid approval compared to other BCI devices [12][13]. - The approval of NEO aligns with China's 14th Five-Year Plan, which emphasizes the development of BCI technology as a future industry, indicating potential for more BCI products to be approved in the future [15].
世界首款!国产脑机接口获批上市,帮助完全瘫痪者恢复手部运动
生物世界·2026-03-18 04:37