国内首张三类证落地！经颅磁刺激设备获批治疗抑郁症

Core Viewpoint - Wuhan Yirui Medical Equipment Technology Co., Ltd. has developed a transcranial magnetic stimulation (TMS) device, which has received the first Class III medical device registration certificate in the field of mental health in China, indicating its approval for use in treating depression [1][2][3]. Company Overview - Wuhan Yirui was established in 2007 and focuses on brain science technology innovation, particularly in magnetic stimulation technology. The company is headquartered in Wuhan and has a professional team for R&D, production, clinical medicine, after-sales service, and training [18]. - The company has over 200 invention patents and has participated in more than 100 research projects, emphasizing its commitment to the industrialization of brain science technology [18]. Product Details - The TMS device is one of the core products of the company, designed to non-invasively stimulate the brain's motor areas to regulate brain function and treat diseases. It features multiple innovative characteristics and technical breakthroughs [4][6]. - The device has received international certifications such as ISO9001 and ISO13485, ensuring product quality and compliance [6]. - It offers various stimulation modes, including single-pulse, double-pulse, and repetitive TMS (rTMS), catering to different clinical needs [6][7]. - The TMS device is applicable for treating a wide range of mental and neurological disorders, including depression, anxiety, insomnia, post-stroke rehabilitation, Alzheimer's disease, chronic pain, and autism [7][12]. Clinical Research - The company has conducted extensive clinical trials in collaboration with several top-tier hospitals across the country, validating the safety and efficacy of the TMS device for treating depression through multi-center randomized controlled trials (RCT) [12][15]. - A nationwide multi-center study on magnetic shock therapy (MST) was initiated to evaluate its efficacy and safety, using the TMS device developed by Yirui [15]. Market Overview - The global market for TMS technology is growing, with the market size in China reaching several hundred million RMB in 2023 and expected to grow from 818 million to 1.595 billion RMB by 2029 [16]. - TMS is recognized as one of the four major brain science technologies of the 21st century, alongside PET, fMRI, and MEG, due to its non-invasive, precise, and safe characteristics [16]. - The company has exported its products to over 10 countries and has a market presence in more than 5,000 medical institutions globally, with over 10,000 units in the domestic market [16][18]. Competitive Landscape - Other major players in the TMS industry include Magventure, Dyansys, Electrocore, Nexstim, Neurosoft, and Cefaly Technology [17].