Yongchuan Technology Secures Approvals for Two Innovative Medical Devices: MH-200 Brain EIT and ECL-100 Thoracic EIT

Supported by the Zhejiang Provincial Key Research and Development Program and with strong backing from departments such as the Zhejiang Provincial Medical Products Administration and the Medical Device Industry Association, the Cerebral Electrical Impedance Tomography System MH-200, developed by Hangzhou Yongchuan Technology Co., Ltd., has been granted an NMPA Innovative Medical Device Registration Certificate. This achievement marks a significant milestone in the strategic development blueprint of Yongchuan’s technological innovation platform. The product can rapidly detect intracranial electrical impedance abnormalities caused by cerebral hemorrhage, offering advantages such as non-invasiveness, non-contact operation, and rapid imaging. It enables physicians to make quick on-site assessments of stroke, successfully filling a market gap in pre-hospital triage for stroke patients.

Meanwhile, with the support of the National Key R&D Program, Hangzhou Yongchuan Technology’s thoracic electrical impedance tomography (EIT) device (model ECL-100) is undergoing approval for market launch through a green channel. This product provides non-invasive, real-time imaging of both global and regional lung ventilation distribution, playing a critical role during the COVID-19 pandemic. This year, backed by national research initiatives and the NMPA’s green-channel approval process, key technological bottlenecks in thoracic EIT devices have been resolved, breaking the import monopoly and officially ushering in the era of domestic production.

The MH-200 is a Magnetic Induction Tomography (MIT) device that measures the distribution of electrical impedance in the human brain via a non-contact method. It enables rapid detection of existing lesions and non-invasive monitoring of disease progression, providing two-dimensional images and one-dimensional metrics to assist physicians in diagnosis and treatment. Currently, the only product on the global market utilizing a similar principle is the Cerebrotech Fluids Monitor CMS-5000 (VISOR) from the United States, which was named one of the “Top 10 Medical Innovations of the Year” by the Cleveland Clinic in 2019. However, it provides only one-dimensional metrics indicating left-right asymmetry.

Yongchuan Technology Electrical Impedance Tomography System MH-200

● China sees over 4 million new stroke cases annually, with treatment costs reaching RMB 40 billion, indicating an enormous demand for diagnosis and treatment.

China has over 100 million patients with cerebrovascular disease. Chronic cerebrovascular disease, when progressing to a certain stage, is prone to triggering acute stroke. In recent years, the incidence of stroke in China has continued to rise, with approximately 4.2 million new cases annually, accounting for about one-quarter of the global total. The Institute of Health Economics under the Ministry of Health once pointed out that stroke imposes an annual socioeconomic burden of RMB 40 billion on China. Recently, The Lancet, in collaboration with the World Stroke Organization, released the report “Practical Solutions to Reduce the Global Burden of Stroke,” which also noted that by 2050, the global economic losses attributable to stroke could reach as high as USD 2.3 trillion. There is substantial market demand for stroke diagnosis and treatment, creating an urgent need to optimize emergency care systems and develop new technologies to alleviate the burden on patients and society.

● Stroke treatment allows for no delay; the MH-200 enables rapid pre-hospital triage and accelerates the treatment process

Early treatment strategies for stroke are highly time-dependent, yet pre-hospital delays still account for the majority of the time from onset to treatment. The MH-200 features a compact design and short detection time, enabling rapid pre-hospital assessment of stroke. This helps reduce pre-hospital delays, allowing more patients to receive treatment within the golden window, thereby improving prognosis. This is precisely the value proposition of the MH-200.

● MH-200 Demonstrates Excellent Performance in Registered Clinical Trials, Bringing Significant Benefits to Stroke Patients

In the preliminary multicenter registry clinical trials, MH-200 demonstrated sensitivity, specificity, and accuracy exceeding 90% in identifying severe hemorrhagic stroke among enrolled stroke patients, with clinical performance meeting expectations.

Yongchuan Technology is dedicated to the R&D of innovative medical devices. The MH-200 precisely addresses the clinical challenge of difficult pre-hospital triage for stroke, offering greater objectivity than experience-based scale methods, along with excellent sensitivity and specificity. For more product information, please add WeChat ID: cb1008612580. In the future, Yongchuan Technology will remain committed to the R&D of electrical impedance technology, continuously launching original high-end medical equipment to serve the public and give back to society.

Pulmonary ventilation imaging techniques enable the assessment of air distribution within the lungs, thereby evaluating pulmonary ventilatory function. During the more than three-year-long COVID-19 pandemic, pulmonary ventilation imaging played a significant role and was utilized for rapid bedside evaluation of lung ventilation and clinical improvement in patients with acute respiratory distress syndrome (ARDS).

● Large Patient Population and Aging Jointly Drive the Release of Demand for Lung Ventilation Imaging

In recent years, the market for pulmonary ventilation imaging and lung function assessment and monitoring in China has experienced rapid growth, driven by supportive national industrial policies and sustained increases in market demand. In China, population aging and the rising number of patients with chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD), have generated substantial demand for regular lung function assessments. Currently, the total number of individuals affected by chronic respiratory diseases in China approaches 100 million, leading to a growing demand for advanced, non-invasive pulmonary ventilation imaging equipment.

● The new EIT technology is non-invasive and radiation-free, offering significant clinical value in continuous monitoring and ICU applications.

Among various pulmonary ventilation imaging techniques, electrical impedance tomography (EIT) offers unique advantages, including being non-invasive, radiation-free, portable, user-friendly, and capable of real-time dynamic imaging, demonstrating excellent performance in continuous and long-term pulmonary monitoring. The Chinese Expert Consensus on EIT Monitoring for Critical Respiratory Diseases states that, as a relatively new and rapidly evolving technology, EIT enables bedside visualized monitoring of pulmonary ventilation and holds significant practical value in the management of critical respiratory conditions.

● Domestic products launched simultaneously, presenting a prime opportunity for the import substitution of EIT devices in China

For a long time, the thoracic Electrical Impedance Tomography (EIT) market was dominated by a single imported German product. With the support of national major special projects, multiple domestically produced EIT products, including the ECL-100 from Hangzhou Yongchuan Technology Co., Ltd., significantly accelerated their market entry in 2024 through the National Medical Products Administration’s green channel. Domestic EIT has now taken center stage, presenting an excellent opportunity for import substitution. The localization of EIT technology can reduce healthcare costs, promote equipment accessibility, and support advancements in respiratory medicine and scientific research. For patients, EIT can be integrated with ventilators to enhance therapeutic efficacy and reduce lung injury, thereby benefiting a vast number of patients with respiratory diseases and those in intensive care units (ICUs) across China.

The ECL-100 Electrical Impedance Tomography (EIT) System is a compact, high-precision device for real-time monitoring of pulmonary ventilation. It enables clinicians to promptly assess ventilation distribution and identify respiratory issues. The system is suitable for patients with respiratory conditions in departments such as pulmonology, cardiology, emergency medicine, pediatrics, intensive care units (ICU), and rehabilitation. It is also applicable for evaluating pulmonary ventilation dysfunction in outpatient clinics, community health centers, and physical examination centers.

Yongchuan Technology Thoracic Electrical Impedance Tomography System ECL-100

The launch of two new products has further enriched Yongchuan Technology’s product portfolio. The company plans to establish a model market for each product and select qualified, high-quality franchise agents across China for distribution. Additionally, Yongchuan Technology is currently pursuing financing initiatives to further expand its market share and strengthen its product line.