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国内首张三类证落地!经颅磁刺激设备获批治疗抑郁症
思宇MedTech· 2025-05-29 09:06
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].
对话依瑞德集团董事长蔡胜安|千元级脑机接口产品有望进入家庭 政策开闸或将催生下一个“家用医疗”风口
Mei Ri Jing Ji Xin Wen· 2025-05-28 11:09
Core Insights - Brain-computer interface (BCI) technology is transitioning from laboratory research to clinical applications, with significant advancements in treating conditions like paralysis and ALS [1] - The approval of the first Class III medical device registration for transcranial magnetic stimulation (TMS) signifies a shift towards standardized treatment options for depression, enhancing the credibility and adoption of such technologies in clinical settings [2][4] - Chinese companies, particularly Yirui De Group, are leading in the development and commercialization of non-invasive BCI technologies, indicating a strong domestic capability in this emerging field [1][2] Industry Developments - The approval of Class III certification for TMS devices is expected to promote orderly development in the industry, allowing more medical institutions to adopt these technologies for depression treatment [2][4] - The integration of multi-modal data for personalized treatment plans is being pursued, with the aim of creating individualized brain maps for more effective therapy [5] - The inclusion of BCI treatments in health insurance plans at an affordable price point is seen as a catalyst for wider adoption and development of home-use devices [8] Clinical Applications - BCI technology is being utilized in various clinical settings, including enabling paralyzed patients to walk and providing communication aids for ALS patients [6][7] - The development of "neural bypass" techniques through BCI represents a breakthrough in understanding and intervening in neural signal transmission, opening new avenues for treating neurological disorders [7] - Future applications may involve combining BCI with pharmacological treatments and rehabilitation training to create comprehensive, personalized therapy protocols [9] Market Dynamics - The increasing number of companies entering the BCI market is indicative of the industry's maturation, presenting both challenges and opportunities for established players [10] - The lack of industry standards and compliance issues may pose risks, but companies with strong technical foundations and regulatory adherence are likely to gain competitive advantages [10] - The focus on developing affordable, effective non-invasive products is crucial for expanding the market reach and achieving the vision of a healthier society [8]
湖北脑科学研究新进展:这一仪器获批三类医疗器械注册证
Di Yi Cai Jing· 2025-05-24 06:29
Group 1 - A Hubei-based company has developed and received the first Class III medical device registration certificate for a transcranial magnetic stimulation (TMS) device in the mental health field in China [1][5] - The TMS technology is a non-invasive treatment method that stimulates brain neurons using magnetic fields, which can be beneficial for conditions such as depression [5][6] - The Chinese brain-computer interface (BCI) market is projected to reach 3.2 billion yuan in 2024, with an 18.8% year-on-year growth, and is expected to grow to 5.58 billion yuan by 2027, with a growth rate of 20% [6] Group 2 - The TMS technology is recognized as one of the four major brain science technologies of the 21st century, alongside PET, fMRI, and magnetoencephalography [5] - Hubei has emerged as a leader in the brain science sector, with several companies like Yirui, Zhonghua Brain Machine, and Green Tech making significant advancements [6] - The conference also showcased other innovations in brain science, including the Ami 3S navigation robot and the T-FUS technology [5]