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Neuralink获FDA认证,脑机接口技术持续突破
Changjiang Securities· 2025-05-12 11:16
Investment Rating - The report maintains a "Positive" investment rating for the industry [8] Core Insights - On May 4, Neuralink's brain-computer interface (BCI) device, Link, received "Breakthrough Device" designation from the FDA, aimed at helping patients with severe speech impairments regain communication abilities. This certification indicates a positive outlook for the clinical application of the Link device, potentially accelerating the research, evaluation, and review processes, thus hastening the large-scale commercialization of brain-computer interfaces [2][5][11] - The report suggests focusing on three main investment themes: 1) Domestic mapping of the advanced overseas invasive brain-computer interface industry chain; 2) Product landing related to non-invasive brain-computer interfaces in consumer scenarios; 3) Downstream application-related targets of brain-computer interfaces [2][11] Summary by Sections Event Description - Neuralink's Link device received FDA's "Breakthrough Device" certification on May 4, aimed at assisting patients with severe speech impairments [5] Event Commentary - The Link device aids patients with neurological diseases such as ALS, stroke, spinal cord injuries, cerebral palsy, and multiple sclerosis in regaining communication abilities. A recent demonstration showed an ALS patient successfully using the Link device to control a computer cursor through thought, showcasing the device's interaction capabilities [11] - Neuralink is expanding its patient registration globally, which may lead to broader applications of BCI technology in health fields, including visual restoration. The Blindsight device, aimed at restoring vision for those with complete blindness, has also received FDA's "Breakthrough Device" certification [11] - The domestic brain-computer interface industry is expected to accelerate under supportive policies, with recent initiatives from the Ministry of Industry and Information Technology and local governments promoting BCI technology development and commercialization [11]