Lepu Medical's AI-Powered ECG Analysis System Becomes First in China to Receive FDA Approval

On November 20, Lepu Medical Technology (Beijing) Co., Ltd. (“Lepu Medical”) announced that its wholly-owned subsidiary, Shenzhen Kaiweier Electronics Co., Ltd., had independently developed the AI-ECG Platform, an artificial intelligence-based automated ECG analysis and diagnostic system. The platform received registration approval from the U.S. Food and Drug Administration (“FDA”) on November 19, 2018, becoming the first AI-enabled ECG product from China to gain FDA clearance.

Cardiovascular disease is the leading cause of death worldwide. The "China Cardiovascular Disease Report 2017," released earlier this year by the National Center for Cardiovascular Diseases, reveals that there are as many as 290 million patients with cardiovascular and cerebrovascular diseases in China, meaning that one in every five people around us is affected by these conditions. Since 1990, mortality rates from cardiovascular and cerebrovascular diseases in both urban and rural areas of China have been steadily rising, reaching nearly 50%.

Electrocardiography (ECG) is the most commonly used clinical diagnostic tool for various cardiovascular diseases, including arrhythmias, ventricular and atrial hypertrophy, myocardial ischemia and injury, and myocardial infarction. It offers several key advantages: First, it is highly cost-effective, with a resting ECG costing only RMB 10–30 and a 24-hour ambulatory ECG ranging from RMB 100 to 300. Second, it is non-invasive and free of side effects. Third, it enjoys high accessibility, as ECG-enabled devices such as smart bands, smartwatches, chest patches, and chest straps have permeated both daily life and clinical settings. Fourth, it provides comprehensive coverage, particularly for the full spectrum of conditions associated with chest pain.

The “AI-ECGPlatform” diagnostic module covers major cardiovascular diseases. It demonstrates absolute advantages over traditional methods in diagnosing arrhythmias (abnormal impulse formation and abnormal impulse conduction), atrial and ventricular hypertrophy, myocardial ischemia, and myocardial infarction, with an accuracy rate exceeding 95%. Notably, its performance in diagnosing conditions such as atrial flutter, atrial fibrillation, complete left bundle branch block, complete right bundle branch block, and pre-excitation syndrome is comparable to that of ECG medical experts.

Lepu Medical stated in its announcement that the “AI-ECG Platform” will be widely applied across four major areas in the future, spearheading 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 standards, and meet the rigid demand for related medical services;

3. ECG monitoring enters the home, enabling patients to perform electrocardiogram 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.

In recent years, numerous AI-assisted diagnostic and therapeutic systems have emerged in China; however, these products must still undergo regulatory review before they can be adopted in clinical practice. The successful approval of the “AI-ECG Platform,” an AI-powered automated ECG analysis and diagnostic system, by the U.S. Food and Drug Administration (FDA) has undoubtedly provided significant encouragement to the industry and stands as a milestone event in China’s medical AI sector.