Hais凯尔's FibroTouch Non-invasive Liver Fibrosis and Steatosis Quantification System Receives FDA Clearance, Marking a Milestone for Chinese High-end Medical Devices Going Global

VCBeat (WeChat ID: vcbeat) has learned that recently, Wuxi Hisky Medical Technology Co., Ltd. independently developedFibroTouch: Non-invasive System for Quantifying Liver Fibrosis and SteatosisThe product series has been certified by the U.S. Food and Drug Administration (FDA) and is approved for marketing and sale in the United States (Registration No.: K173595).This marks that China’s domestically produced high-end medical devices with independent intellectual property rights, represented by FibroTouch, have reached the level of developed countries.

In recent years, China’s medical device industrial policies have been frequently implemented, continuously encouraging innovation in domestically produced medical devices and promoting their global expansion. At the National Science and Technology Work Conference held in January this year, Wan Gang, the then Minister of Science and Technology, proposed accelerating the localization, high-end development, branding, and internationalization of medical devices. Furthermore, a series of policies, including the Measures for the Standardized Management of Medical Devices and the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices, have prioritized “accelerating the approval of innovative medical devices” and “localizing high-end medical devices,” thereby encouraging and supporting the development of China’s domestic medical device industry.

Supported by favorable policies, China’s high-end medical device enterprises have responded proactively, infusing the market with vibrant vitality. The “China Medical Device Industry Development Report (2017)” indicates that, overall, China’s medical device industry has experienced rapid growth in recent years. The year-on-year growth rate of main business revenue for manufacturing enterprises above the designated size ranged from 11.66% to 22.20%, significantly outpacing the growth rate of the national economy during the same period. The landscape for research, development, and production of high-end medical devices is promising, with innovative products emerging at an accelerated pace.

Amid the sustained positive momentum in China’s high-end medical device market, FibroTouch’s successful FDA clearance has opened the door for Hisky Medical to enter the U.S. market and injected new momentum into its accelerated global expansion. Hisky Medical has emerged as a representative example of Chinese independent brands “going global.”

Hiskel, co-founded by three Tsinghua University PhDs—Shao Jinhua, Sun Jin, and Duan Houli—is a high-end medical equipment enterprise with independent intellectual property rights in the field of non-invasive detection of liver fibrosis. Its flagship product, FibroTouch, a non-invasive system for quantifying liver fibrosis and steatosis, has obtained both the Medical Device Registration Certificate from the People's Republic of China and CE certification from the European Union. This product holds broad application prospects in liver health screening for the general population, as well as in diagnosing the severity of liver fibrosis and monitoring treatment progress among patients with liver diseases.

Currently, transient elastography has been recommended by guidelines from major global hepatology associations, including the World Health Organization, the American Association for the Study of Liver Diseases, the European Association for the Study of the Liver, the Asian Pacific Association for the Study of the Liver, and the Chinese Society of Hepatology.

Since its market launch in 2013, FibroTouch has experienced rapid market growth. By leveraging transient elastography technology, this product enables non-invasive detection of liver elasticity parameters with both qualitative and quantitative capabilities. It boasts a detection success rate approaching 100%, thereby breaking the monopoly held by foreign technologies.FibroTouch has been widely adopted in China, with nearly 1,000 medical institutions across the country having introduced the technology. Due to its outstanding diagnostic efficacy, it has garnered consistent recognition from Chinese scholars, physicians, and patients alike.

Meanwhile, Hisky has taken root in the Chinese market and expanded globally. Adhering to its “going global” strategy, Hisky strives to leverage innovative Chinese technologies to provide leading, high-quality services to a broader population of liver disease patients both domestically and internationally. Currently, the FibroTouch product series has been deployed across Southeast Asia, the Middle East, Eastern Europe, Latin America, Africa, and other regions.

Taking King Chulalongkorn Memorial Hospital and Vejthani Hospital as examples, these two highly influential and renowned hospitals in Thailand have transformed the local lag in liver-related technologies by introducing the FibroTouch detection system. This innovation has brought non-invasive diagnostic technology for liver diseases to patients, effectively addressing issues such as complex testing procedures, prolonged diagnosis times, and high medical costs in the field of hepatology.

With the FibroTouch detection system receiving FDA clearance and successfully entering the U.S. market, it will gain access to more international markets. FibroTouch will continue to leverage its non-invasive and quantitative features to usher in a new era of non-invasive diagnosis and assessment of liver fibrosis in the field of hepatology in the United States, making greater contributions to the diagnosis and treatment of liver diseases.

Dr. Shao Jinhua, Founder of Hisky Medical, stated, “FDA clearance represents significant recognition of our scientific achievements. Moving forward, we will remain committed to independent innovation and R&D while engaging in relevant academic collaborations. Our goal is twofold: to promote the global adoption of advanced Chinese research outcomes, and to introduce cutting-edge international technologies and advancements in liver disease diagnosis into China. By strengthening international academic cooperation, we aim to contribute to human health and help build a shared future for global health.”