LEPU Medical's AI-Powered ECG Analysis Software Receives NMPA Approval as Another Class III AI Medical Device

On February 7, 2020, VCBeat (WeChat ID: vcbeat) learned that Shenzhen Kaiwoer Electronics Co., Ltd., a wholly-owned subsidiary under the AI Division of Lepu Medical Technology (Beijing) Co., Ltd. (hereinafter referred to as “Lepu Medical”), had independently developed an artificial intelligence “ECG Analysis Software” (AI-ECG Platform), which received registration approval from the National Medical Products Administration (hereinafter referred to as “NMPA”).

It is reported that the product received registration approval from the U.S. Food and Drug Administration (hereinafter referred to as the “FDA”) in November 2018 and obtained CE certification in the European Union in November 2019. The AI-based “ECG Analysis Software” (AI-ECG Platform) has become the first AI-enabled ECG product approved for registration in China, and remains the only one currently holding approvals from the National Medical Products Administration (NMPA), the FDA, and CE certification. This marks another Class III medical device related to artificial intelligence to gain approval, following Keya Medical’s “Coronary Flow Reserve Fraction Software.”

Cardiovascular disease is the leading cause of death worldwide. According to the "China Cardiovascular Disease Report 2017" released by the National Center for Cardiovascular Diseases, there are as many as 290 million patients with cardiovascular and cerebrovascular diseases in China, meaning that one in every five people around us suffers from such conditions. From 1990 to the present, the mortality rates of cardiovascular and cerebrovascular diseases in both urban and rural areas of China have been rising steadily, reaching approximately 50%.

Electrocardiography (ECG) is the simplest, fastest, and most cost-effective clinical examination method for various cardiovascular diseases, serving as the cornerstone of cardiovascular diagnostic testing. The “AI-ECG Platform,” an artificial intelligence-based ECG analysis software, leverages deep learning technologies and is trained on tens of millions of clinical ECG data points. By automatically analyzing ECG events such as arrhythmias, myocardial infarction, ventricular hypertrophy, and ST-T abnormalities, the platform has achieved an overall accuracy rate exceeding 95%, enabling rapid and accurate diagnosis of static ECGs. Furthermore, it supports the development of ECG networks both within and outside hospitals, thereby effectively enhancing the informatization and intelligent capabilities of healthcare institutions.

Leveraging this technological platform, Lepu Medical has developed multiple devices, including AI chip-enabled electrocardiogram (ECG) machines, providing a comprehensive solution that covers pre-hospital screening, in-hospital examination and monitoring, and post-hospital rehabilitation monitoring. This initiative supports the construction of ECG information systems in hospitals both domestically and internationally, enhancing the efficiency and service quality of ECG diagnosis and treatment.

Previously, Lepu Medical stated in an announcement that the “AI-ECG Platform” will be widely applied in four major areas in the future, leading a revolution in the electrocardiogram industry:

1. A large number of primary hospitals, private clinics, health examination centers, community health service centers, and elderly care institutions lack professional electrocardiogram (ECG) physicians. The application of this product will establish an integrated technical service chain, enabling localized and rapid ECG analysis and diagnosis for patients at these facilities;

2. Liberate the workforce of specialized electrocardiogram (ECG) physicians in large hospitals, improve work efficiency and diagnostic accuracy, and meet the rigid demand for relevant medical services;

3. ECG monitoring enters the home, enabling patients to perform ECG monitoring at home just as they monitor blood pressure and blood glucose;

4. The ECG analysis and diagnostic capabilities of wearable devices have been elevated to the level of professional physicians, enabling wearables (such as smartwatches and fitness bands) to truly provide medical-grade data for monitoring patients’ ECG status, thereby further expanding their widespread application.