On April 6, 2023, led by Professor Tang Yida, Vice President of Peking University Third Hospital, and Professor Shao Chunli of the Department of Cardiology, the first batch of 20 subjects were successfully enrolled, and the wearing process was smooth and successful.

The first batch of 20 subjects were all healthy subjects. The clinical study adopted a prospective, multi-center, single-group exploratory research design, with average daily wearing time, total wearing days, wearing comfort, false alarm rate, and skin adverse reaction incidence as observation endpoints. The compliance and safety of wearable automatic external defibrillators were preliminarily evaluated to provide a basis for further confirmatory clinical research.
This clinical study is the first clinical study of wearable automatic external defibrillators in China, and it has received the full attention and strong support of Professor Hua Wei, Chairman of the Electrophysiology and Pacing Branch of the Chinese Medical Association. At the same time, it indicates that in the near future, patients with high risk of sudden cardiac death, who are not suitable for or refuse to implant ICDs, will have safer protection, and provide more health benefits for such patients in the short term.

At present, VIS has successfully developed AED. After it was put on the market, it successfully treated many patients who died suddenly outside the hospital. With the development of the feasibility test of wearable automatic external defibrillator, the pace of product registration and listing is also accelerating. In the near future, a platform combining the advantages of data transmission will be formed to build a ventricular arrhythmia therapy + data service management. At that time, the passive treatment of sudden cardiac death will be transformed into active health management with prevention as the main focus, which will eventually provide a strong escort for the life and health of patients. May every heart beat healthily!

Company Introduction

VIS Medical Technology is an innovative medical technology company focusing on ventricular arrhythmia prevention and treatment and heart rhythm data services. The company is committed to providing the world’s leading full-process complete solution for ventricular arrhythmia prevention, monitoring, treatment, and rehabilitation, and creating a non-invasive ventricular arrhythmia and sudden cardiac death prevention and treatment service platform. Two products with completely independent intellectual property rights have been developed – wearable automatic external defibrillator (WCD) and automatic external defibrillator (AED), and a data platform has been initially established to provide remote services for users of such products.

The wearable automatic external defibrillator (WCD) is the first of its kind in China. Based on the innovation and urgent clinical needs of the wearable automatic external defibrillator, the product was approved by the Medical Device Technology Review Center of the National Medical Products Administration on January 7, 2021, and entered the special review procedure for innovative medical devices, which will break the foreign monopoly and enhance my country’s ability to prevent and treat sudden cardiac death for patients from in-hospital to out-of-hospital.

As a potential unicorn enterprise of innovative medical devices at the two levels of Jiangsu Province and Suzhou City, the “Wearable Automatic External Defibrillator (WCD) and Sudden Death Risk Artificial Intelligence Assessment System” project of Vivis Medical was successfully selected as the “unveiling unit” in the category of intelligent monitoring and life support products in October 2022, becoming the main body of innovative task research.

In the future, Vivis Medical will extend the development of the world’s first multi-parameter sudden death risk assessment system through the promotion of the wearable series of ventricular arrhythmia products and remote data service management. Through this system, Vivis will lead the transformation of passive treatment of sudden cardiac death into precise treatment of ventricular arrhythmia rhythm management combined with prevention and treatment.