Haisker's non-invasive liver fibrosis detection system FibroTouch is FDA-approved

Arterial Network has learned that the FibroTouch series of non-invasive liver fibrosis and fat variable detection systems independently developed by Wuxi Haiskel Medical Technology Co., Ltd. have been certified by the US Food and Drug Administration (FDA) and approved for sale in the United States. This marks the domestic high-end medical equipment with China's independent intellectual property rights represented by FibroTouch reaching the level of international developed countries.

In recent years, China's medical device industry policies have been frequently exerted, constantly encouraging domestic medical device innovation and promoting domestic medical devices to “go global”. At the National Science and Technology Work Conference in January this year, the then Minister of Science and Technology Wan Gang proposed to accelerate the localization, high-end, branding and international development of medical devices. In addition, a series of policies such as the “Measures for the Standardization of Medical Devices” and the “Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices” have focused on “accelerating the approval of innovative medical devices” and “localization of high-end medical devices”. Encourage and support the development of domestic medical device industry .

With the support of the policy, China's high-end medical device companies responded positively and the market showed active vitality. "China Medical Device Industry Development Report (2017)" shows that from the overall perspective of China's medical device industry in the past few years, China's medical device industry has developed rapidly, and the growth rate of the main business income of production enterprises above designated size is 11.66-22. .20%, significantly higher than the growth of national economic development in the same period, the high-end medical equipment research and development situation is gratifying, and innovative products are accelerating.

In the domestic high-end medical device market continues to develop well, the FibroTouch successfully passed the FDA certification to open the door for Haisker to enter the US market, and also injected momentum into Hayskel's accelerated global deployment. Haiskel became a typical enterprise of the Chinese national independent brand “going out”.

Haiskeer was founded by Shao Jinhua, Sun Jin and Duan Houli, three PhD students of Tsinghua University, and has high-end medical equipment enterprises with independent intellectual property rights in the field of non-invasive detection of liver fibrosis. Its product non-invasive liver fibrosis and fat variable detection system FibroTouch has obtained the People's Republic of China medical device registration certificate and EU CE certification. The product has broad application prospects in the liver screening of the general population, the diagnosis of liver fibrosis in the liver patient group, and the tracking and evaluation of the treatment process.

At present, transient elastography has been recommended by the World Health Organization, the American College of Hepatology, the European Society of Liver Diseases, the Asia-Pacific Liver Disease Society, and the Chinese Medical Association Liver Diseases Branch.

Since the launch of FibroTouch in 2013, the market has grown rapidly. Because the product uses transient elastography to enable non-invasive detection of liver elastic parameters, and can be qualitatively quantified, with a detection success rate close to 100%, breaking the monopoly of foreign technology. At present, FibroTouch has been widely used in China, and nearly 1,000 medical institutions have been introduced nationwide. Because of its outstanding results in diagnosis, it has been unanimously recognized by domestic scholars, doctors and patients.

At the same time, Haiskel has sprouted from the Chinese market and is expanding towards the global market. Haiskeer adheres to the strategy of “going out” and strives to provide leading and high-quality services for more liver patients at home and abroad with Chinese innovative technology. Currently, FibroTouch products have been launched in Southeast Asia, the Middle East, Eastern Europe, Latin America and Africa.

Take the King Chulalongkorn Memorial Hospital and the Vejthani Hospital, the most influential hospitals in Thailand, and changed the local hospitals by introducing the FibroTouch detection system. The backward technology in the liver field has brought about the innovation of liver non-invasive diagnostic technology for patients with liver disease, effectively solving the problems of complicated detection procedures, long diagnosis time and large medical expenses in the field of liver diseases.

As the FibroTouch inspection system is FDA-approved, it will successfully enter the US market and will gain more access to the international market. FibroTouch will continue to use its non-invasive and quantitative features to open a new chapter in the diagnostic evaluation of non-invasive liver fibrosis in the field of liver disease in the United States, and make more contributions to the diagnosis and treatment of liver diseases.

Dr. Shao Jinhua, founder of Haiskel, said, “The FDA certification is a great recognition of our scientific research results. In the future, we will continue to adhere to independent innovation and research and development, and carry out relevant academic cooperation. On the one hand, let China's advanced scientific research and transformation results' Going out, on the other hand, I hope that I can introduce more international top-level liver disease diagnosis related technologies and progress, and strengthen international academic cooperation to contribute to human health and help build humanity. Healthy destiny community."

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