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Suzhou R&D! The first made-in-China wearable defibrillator enters the special approved "green channel"

2021 - 04 - 21

As people’s life pressures increase, sudden death has become a major “killer” that threatens lives. Yesterday, ViVest Medical, based in the Suzhou Biomedical Industrial Park in Suzhou Industrial Park, announced that its wearable electrocardiographic defibrillator (WCD), which was the first to develop in China, was approved by the Medical Device Technology Review Center of the National Medical Products Administration to enter the special “Review Process of Innovative Medical Devices”. This means that the wearable ECG defibrillator device developed by ViVestMedical is expected to become the first made-in-China product on the market, breaking the monopoly of foreign producers.

Wearable ECG defibrillator devices are Class-III Medical Devices with high technical barriers and integration difficulty among cardiac medical devices. They integrates cardiac electrophysiology, automatic defibrillation treatment algorithms, integrated circuits, flexible electrode sensors, 5G IoT, high-energy capacitance, ECG algorithm and automatic glue spraying technology. However, due to the extremely high threshold of R&D technology, most of the relevant equipment on the market are mainly imported, and the current market size for its products and services is about 13.8 billion yuan per year.

ViVest Medical settled in Suzhou Biomedical Industrial Park in 2019. It is an innovative enterprise focusing on the research and development of medical devices related to cardiac rhythm management and rhythm data services. At present, the company has a headquarter and R&D center in Suzhou Biomedical Industrial Park, and has 1,005 square meters of manufacturing and office plants. Since its establishment, ViVest Medical has been focusing on the research and development of wearable ECG defibrillators. It is reported that the products that entered the "green channel" for special approval this time can not only be effectively used in the clinical short-term (1 to 3 months) risk prevention and ventricular fibrillation treatment of high-risk patients with sudden cardiac death, but also advantages of convenience, recyclable usability and reliable defibrillation effect.

As reported, by the end of 2020, so far there are no wearable ECG defibrillator has been approved in China, and the product developed by ViVest Medical is expected to become the first made-in-China product. In the future, the company will also build an ECG clinical data service platform, launch the world’s first sudden death risk assessment system, provide a complete set of solutions from monitoring, prevention, treatment to rehabilitation for patients in China and around the world, and fully promote cardiac defibrillation from passive treatment Turn to precise prevention of sudden cardiac death.

As ViVest Medical enters the green channel for special approval in the field of medical devices, 14 products from 10 medical device companies in Suzhou Biomedical Industrial Park have entered the “green channel” for national medical device innovation product approval; In the field of similar medical devices, it has obtained 105 product registration certificates and 27 product production licenses.