Lepu Medical's AI-ECG Platform Receives FDA Acceptance and Enters Clinical Use: A Breakthrough in Artificial Intelligence-Powered Electrocardiogram Diagnosis

In recent years, artificial intelligence (AI) technology has garnered significant attention, emerging as one of the key terms in China’s technological development. It is being rapidly integrated into various aspects of industrial growth and social life.

On March 24, during the 16th China Interventional Cardiology Conference (CIT), Lepu Medical Technology (Beijing) Co., Ltd. (hereinafter referred to as “Lepu Medical”), a leading health platform enterprise in China dedicated to the “full ecosystem of cardiovascular disease,” grandly unveiled its independently developed “AI-ECG Platform: Artificial Intelligence-Based Automatic Analysis and Diagnosis System for Electrocardiograms.” This launch marks the official debut of China’s first AI-powered automatic analysis and diagnosis system for electrocardiograms.

Leading Chinese cardiovascular experts, including Academician of the Chinese Academy of Engineering Professor Han Yaling from the General Hospital of Shenyang Military Command, Professor Ma Changsheng from Beijing Anzhen Hospital, and Professor Pan Xiangbin from Fuwai Hospital, have highly affirmed and expressed strong expectations for the AI-ECG Platform system. The product has currently been accepted by the U.S. Food and Drug Administration (FDA).

Electrocardiography is the simplest, fastest, and most cost-effective clinical diagnostic method for various cardiovascular diseases—including arrhythmias, ventricular and atrial hypertrophy, myocardial ischemia and injury, and myocardial infarction—and serves as the cornerstone of cardiovascular disease evaluation.

Due to the inherent complexity and variability of electrocardiogram (ECG) signals, traditional ECG analysis techniques have certain limitations and cannot achieve truly automatic, rapid, and accurate analysis. Consequently, interpretation must rely on professional physicians. However, most medical institutions, particularly primary care hospitals, suffer from a scarcity of specialized ECG physicians. This shortage limits the effectiveness of ECG in disease diagnosis and hinders timely and accurate diagnosis, prevention, and treatment for the vast number of cardiovascular disease patients in primary care settings.

Amid the overarching trend of leveraging artificial intelligence and big data to drive deep integration with healthcare systems and propel medical reform, Lepu Medical has responded proactively by utilizing AI to overcome bottlenecks in electrocardiogram (ECG) technology.

Lepu Medical’s AI ECG team extracted a big data sample of 25 million electrocardiograms from the ECG examination records of 300,000 patients to train deep convolutional neural network models.

As the first artificial intelligence-based medical technology in China to achieve industrialization for automated ECG analysis and diagnosis, the AI-ECG Platform is also among the world’s leading AI medical technologies for electrocardiographic analysis and diagnosis. Its diagnostic capabilities cover major ECG diagnostic events. Compared with traditional ECG analysis and diagnostic methods, it demonstrates significant advantages in detecting arrhythmias, particularly premature beats, tachycardia, escape beats, conduction blocks, atrial fibrillation, and atrial flutter, achieving an accuracy rate of over 95.0%, comparable to the expertise of cardiologists. The platform boasts broad application prospects in various settings, including routine clinical static ECG analysis and diagnosis, real-time monitoring and early warning via ambulatory ECG (Holter), as well as bedside monitoring and home-based surveillance.。

Traditional ECG algorithms are limited in their ability to identify P waves and T waves, failing to analyze the P-QRS-T complex as an integrated waveform; meanwhile, manual ECG interpretation relies heavily on physicians’ professional expertise and experience, and is subject to various influencing factors.Therefore, the advantages of the Lepu AI ECG Platform over the other two are more pronounced, particularly in special types of cardiovascular diseases. It can accurately identify atrial flutter and atrial fibrillation with complete right bundle branch block, as well as second-degree atrioventricular block (Wenckebach and Mobitz types), which are challenging for traditional methods to detect.。

The AI ECG Platform was deployed at Ujiali in August 2017. After six months of practical application, it has been demonstrated that the platform’s diagnostic capability for arrhythmic events and cardiac conduction abnormalities has reached the level of professional physicians, with its analysis and diagnosis of certain complex cases even surpassing that of specialists.

The company has filed over a dozen Chinese and international patents for this technology.

The registration of this product marks a milestone for Lepu Medical in the field of AI healthcare, representing the first among our multiple AI medical projects to achieve industrialization. The company is also actively advancing the domestic and CE certification processes for this product. As the first industrialized AI medical technology in China, it ranks among the world’s leading AI solutions for ECG analysis and diagnosis.

This technology is expected to be widely applied in the following areas, bringing about a revolution in the electrocardiogram (ECG) industry:

1. A large number of primary care hospitals, private clinics, health examination centers, and elderly care institutions lack professional electrocardiogram (ECG) physicians; the application of this product will enable localized and rapid ECG analysis and diagnosis for patients at these facilities.

2. Empower the central hospital’s ECG diagnostic services, improve the efficiency of ECG analysis and diagnosis, liberate professional cardiologists from routine tasks, and enable them to better focus on urgent, critical, and complex cases, thereby providing higher-quality care to patients.

3. The integration of ECG monitoring into home care enables patients to perform both static and dynamic electrocardiographic monitoring at home, similar to how they monitor blood pressure and blood glucose levels.

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 deliver truly medical-grade data for monitoring patients’ cardiac conditions, thereby further expanding their application scope.

AI-ECG Platform: R&D Manufacturer of the AI-Based Automatic ECG Analysis and Diagnosis SystemLepu Medical Technology (Beijing) Co., Ltd. is a leading specialized industrial group in China, focusing on medical devices, pharmaceuticals, and healthcare services for the treatment of cardiovascular diseases. The company is committed to developing products for the prevention, diagnosis, treatment, and rehabilitation of cardiovascular conditions, striving to provide high-quality, domestically produced medical products and services. Its independently developed and manufactured coronary drug-eluting stents, as well as Atorvastatin Calcium (a domestic alternative to the imported brand Lipitor) and Clopidogrel Bisulfate (a domestic alternative to the imported brand Plavix), have been widely adopted and demonstrated favorable therapeutic efficacy, contributing to more scientific prevention and treatment of cardiovascular diseases.

The development and industrialization of the AI-ECG Platform will facilitate the seamless integration of primary prevention, treatment, rehabilitation, and secondary prevention of cardiovascular diseases, thereby providing more convenient and efficient full-lifecycle, comprehensive care for patients with cardiovascular conditions.

To promote the widespread adoption and application of this technology, the company acquired full ownership of Shenzhen Kaiwoer Electronics Co., Ltd. in December 2017. This company possesses FDA, CE, and CFDA registrations for electrocardiographs and patient monitors, along with established manufacturing platforms, thereby enabling the rapid establishment of an industrialization platform for this technology.。