首款侵入式脑机接口医疗器械获批上市

Core Viewpoint - The approval of the brain-machine interface hand function compensation system by the National Medical Products Administration marks the global launch of the first invasive brain-machine interface medical device, entering the clinical application phase [1]. Group 1: Product Overview - The product consists of several components including an implanted brain-machine interface, a set of implanted EEG electrodes, a brain signal transceiver, a pneumatic glove device, a disposable surgical tool kit, EEG decoding software, medical testing software, and clinical management software [1]. - It is designed for patients with quadriplegia due to cervical spinal cord injuries, specifically those aged 18 to 60 with C2 to C6 spinal injury ratings of A to C, who have had a stable condition for at least six months after standardized treatment [1]. Group 2: Clinical Application and Results - The product utilizes minimally invasive implantation techniques and wireless power communication technology [1]. - Clinical trial results indicate that subjects using this product have significantly improved their hand grasping abilities, thereby enhancing their quality of life [1].