On February 13, 2023, the Artificial Intelligence Medical Device Innovation Cooperation Platform and the China Academy of Information and Communications Technology jointly led the industry representative enterprises to jointly compile the “White Paper on the Development of Artificial Intelligence Medical Device Industry” and officially released it.

As a representative enterprise in the industry, Weiweisi was fortunate to participate in the compilation of the white paper. “Wearable Automatic External Defibrillator (WCD) and Sudden Death Risk Artificial Intelligence Assessment System” was selected as a typical case of intelligent monitoring and life support products in the white paper.

Starting from demand, clinical orientation

The first wearable automatic external defibrillator in China

The “14th Five-Year Plan” period is a critical period for my country to achieve a comprehensive upgrade and transformation of medical devices to digitalization and intelligence, and it is also a major opportunity period for the development of artificial intelligence medical devices.

Background introduction

In October 2022, the General Office of the Ministry of Industry and Information Technology and the General and Planning Finance Department of the National Medical Products Administration jointly issued the “Notice on the Announcement of the Shortlisted Units for the Artificial Intelligence Medical Device Innovation Task”. The “Wearable Automatic External Defibrillator (WCD) and Sudden Death Risk Artificial Intelligence Assessment System” project of Vivis Medical was successfully selected as the “Shortlisted Unit” in the category of intelligent monitoring and life support products, becoming the main body of the innovation task.

The wearable automatic external defibrillator (hereinafter referred to as WCD) developed by Vivis Medical has core technologies such as biphasic truncated exponential wave, wearable technology, VF/VT rhythm recognition algorithm, and artificial intelligence ECG data analysis. It is suitable for people with high risk of short-term sudden death, including those at high risk of early acute myocardial infarction, those at high risk of ventricular tachycardia/ventricular fibrillation after revascularization treatment, and those waiting for heart transplantation or requiring ventricular assist device treatment.

WCD realizes long-term, continuous automatic ventricular fibrillation/ventricular tachycardia recognition and analysis, and can perform fully automatic defibrillation treatment on patients. It has the advantages of simple and convenient wearing, flexible use cycle, reusability and reliable defibrillation effect. WCD makes it possible for people at high risk of sudden cardiac death to live at home, extending the time window for doctors to treat patients.

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At present, domestic substitution is gradually being realized in various key segments. Improving independent innovation capabilities, promoting high-quality development of the industry, redefining international standards and making international layouts have become important missions for domestic medical device companies.

The launch of the wearable automatic external defibrillator independently developed by VIS will become the first in China, breaking the foreign monopoly and improving my country’s ability to prevent and treat sudden cardiac death in patients from in-hospital to out-of-hospital.

“Digital Intelligence” Fusion
China’s Innovation in the Field of Artificial Intelligence

The AI ​​Assessment System for Sudden Cardiac Death Risk is based on the 24-hour dynamic ECG big data collected by patients wearing WCD for 60-90 consecutive days, and establishes a malignant ventricular arrhythmia ECG database. Using big data and deep learning technology, an AI assessment system for sudden cardiac death risk assessment is developed to assess the risk of long-term, short-term, and ultra-short-term sudden cardiac death in patients with cardiovascular disease, and change the passive defibrillation treatment of ventricular tachycardia/ventricular fibrillation rhythm to prevention, monitoring, treatment, and rehabilitation services. It has significant clinical significance for the prevention and treatment of sudden cardiac death.

Looking to the future, Weiweisi Medical, as a potential unicorn company of innovative medical devices at the two levels of Jiangsu Province and Suzhou City, will focus on the development of the application of artificial intelligence technology in sudden death risk assessment through the long-term big data characteristics of ventricular arrhythmia wearable products, combined with my country’s rapidly developing 5G data transmission advantages, to greatly extend the patient benefits of WCD products, and transform passive defibrillation treatment of sudden cardiac death into active health management with prevention as the main focus.