Lepu Medical Advances AI-ECG Platform Commercialization with Global Regulatory Milestones and Integrated Healthcare Ecosystem

Recently, Lepu Medical officially released its independently developed “AI-ECG Platform: Artificial Intelligence Automatic Analysis and Diagnosis System for Electrocardiograms.” At the launch event, Chen Juan, Deputy General Manager of Lepu Medical, stated that the AI-ECG Platform is the first AI medical technology to achieve industrialization in China and a leading internationally deployed AI-based intelligent analysis and diagnostic technology for electrocardiograms.

Currently, many medical AI companies in China are still in the stages of product refinement and business model exploration. Following the FDA’s acceptance of its AI-ECG product, Lepu Medical directly proposed a development strategy for the industrialization of AI medical technology and has already made multifaceted strategic arrangements in advance. To this end, VCBeat interviewed Liu Chang, Head of AI at Lepu Medical, to gain a detailed understanding of how Lepu Medical is achieving the industrialization of AI in healthcare.

AI in healthcare is a technology, not a product; its implementation must be integrated into other software or medical device products.

Liu Chang stated that Lepu Medical, as a medical device company with years of deep expertise in the healthcare sector, aims to build a comprehensive ECG ecosystem centered on its AI-ECG technology. This ecosystem will encompass various ECG hardware acquisition devices, an automated analysis software platform, and expert services, thereby leading a technological revolution in the field of electrocardiography. The goal is to extend AI-based ECG analysis, diagnosis, and services into hospitals, primary care settings, and homes, meeting the growing domestic and international demand for ECG examinations.

Currently, Lepu Medical is first leveraging its AI-ECG assisted diagnostic system to upgrade the static and dynamic electrocardiogram (ECG) products under its Kaiwoer and Youjiali brands, thereby enhancing their competitiveness in the industry.

In the field of static electrocardiography, Shenzhen Kaiwoer Electronics Co., Ltd., a wholly-owned subsidiary of Lepu Medical, is a well-known domestic R&D and manufacturing enterprise for ECG equipment. To date, Kaiwoer has obtained certifications from China’s CFDA, the EU CE, and the US FDA for multiple ECG products. Various static electrocardiographs and multi-parameter patient monitors developed by Kaiwoer are being sold in both domestic and international markets.

The Lepu AI-ECG Platform can be deployed in hospital departments to establish an ECG analysis and diagnostic network system integrated with an AI-ECG assisted diagnosis system. Kaiwoer’s static ECG devices can be directly connected to this system, enabling hospitals—particularly primary care institutions—to deploy the AI-based ECG analysis and diagnostic system easily and rapidly.

This means that by using Kaiwoer’s static ECG devices, the entire workflow—from ECG examination and data upload to AI analysis and report generation—can be automatically completed. Once reviewed and confirmed by physicians, the reports can be printed. As an AI-assisted diagnostic system for ECG, the AI-ECG Platform allows physicians to modify the AI-generated diagnostic conclusions and regenerate the reports based on their revisions.

Liu Chang also emphasized that, to address the shortage of specialized physicians in some primary healthcare institutions, AI-ECG can provide tiered diagnosis and treatment services based on remote static electrocardiogram (ECG) analysis. When using Kaiwoer static ECG devices, primary hospitals can directly transmit ECG data via secure network connections to the ECG department at a central hospital. There, the AI-ECG Platform performs preliminary diagnostic analysis for review by cardiologists at the central hospital. The finalized reports are then delivered electronically from the central hospital back to the primary hospitals for patients.

Patients are charged according to the standard fee schedule for routine static electrocardiogram (ECG) examinations, with no additional fees required. For hospitals, the procurement of ECG equipment and software proceeds as usual, except that the software now includes a clinically validated AI-ECG assisted diagnostic system. This approach significantly reduces the time central hospital physicians spend on diagnosis and treatment, while the AI-ECG system comprehensively improves the accuracy of ECG analysis, thereby assisting physicians in making accurate diagnoses.

By integrating AI-ECG with Kaiwoer’s hardware products, an intelligent automated ECG analysis and diagnostic system has been specifically developed for hospital departments. Furthermore, AI-ECG technology has comprehensively enhanced Kaiwoer’s core competitiveness, laying a solid foundation for the company’s further research and development of intelligent ECG examination terminal devices.

In the field of dynamic electrocardiography (ECG), Lepu Medical’s subsidiary, Youjiali, has been engaged in research since 2003. Currently, it holds the largest market share in this sector, with its solutions deployed in nearly 1,000 hospitals, including numerous top-tier tertiary hospitals and many primary care institutions.

The profitability of dynamic ECG monitoring primarily stems from services. Patients wear and use Youjiali’s dynamic ECG device (Xin An Bao), and hospitals charge corresponding fees in accordance with national medical insurance regulations. The specific charges are linked to the type of service provided, such as whether real-time alerts are included and the duration of monitoring.

The hospital uploads patients’ wearable device data to Ucare’s cloud server. The data first undergoes preliminary analysis and diagnosis via the AI-ECG platform system, followed by further review by Ucare’s physician team. The diagnostic report is then sent back to the hospital, where professional physicians conduct a final review before printing and issuing the report to the patient. In essence, the hospital outsources this segment of its operations to Ucare.

The AI-ECG Platform began its trial operation at Youjiali in August 2017. Over the past six months, it has analyzed 24-hour ambulatory electrocardiogram (ECG) data from tens of thousands of patients. Its performance and analytical accuracy have been fully recognized, demonstrating significant advantages in diagnosing arrhythmic events such as supraventricular and ventricular premature beats, atrial flutter and atrial fibrillation, ventricular tachycardia, conduction blocks, and pre-excitation syndrome. Highly favored by Youjiali’s medical team, the platform has comprehensively enhanced the competitive edge of Youjiali’s ambulatory ECG analysis services.

AI-ECG also supports Ujia Li’s real-time alert service by providing accurate and timely analysis. Ujia Li’s team of professional physicians, on duty 24/7, continuously monitors the real-time alert data transmitted via mobile communication networks from Xin An Bao. Building upon AI-ECG analysis, they perform precise, professional assessments and implement necessary interventions to safeguard the lives of patients in critical condition.

For patients, there are currently no additional fees for AI-ECG; they continue to pay according to national charging standards. For Youjiali, AI-ECG has enhanced its core competitiveness.

Liu Chang stated that Lepu Medical has essentially covered hospital application scenarios for both dynamic and static electrocardiography, while possessing a complete industrial chain encompassing software and hardware R&D, manufacturing, and a team of physicians. Once regulatory approvals from the CFDA, FDA, and CE are obtained, these application models can be immediately launched and promoted in domestic and international markets. The FDA has already accepted their application, with certification expected in the second half of the year; meanwhile, CFDA and CE registration processes are underway, and submission of documentation will follow shortly.

Regarding CFDA certification, Liu Chang stated that the process is currently being expedited. In essence, AI-ECG merely updates traditional analysis algorithms by employing advanced artificial intelligence techniques, thereby elevating the sensitivity and positive predictive value of arrhythmia event detection to the level of professional electrocardiographers. Nevertheless, the system remains positioned as an auxiliary diagnostic tool.

The second application scenario of Lepu Medical’s AI electrocardiogram (ECG) system is to serve institutions lacking professional ECG physicians, such as primary care hospitals, private clinics, health examination centers, and elderly care facilities.

There is a shortage of physicians at the primary care level who are capable of interpreting electrocardiograms (ECGs). If ECG devices and AI-ECG analysis and diagnostic platforms were simply deployed to numerous primary healthcare institutions without additional support, physicians might lack the competence to review AI-generated reports and thus would be unable to sign off on them for confirmation. Therefore, Lepu Medical’s strategy involves providing centralized training to primary care physicians during product rollout. This training aims to equip them with basic ECG interpretation and analysis skills, as well as an understanding of the capabilities of AI-ECG analysis and diagnostics. In this way, while empowering primary care settings with new technology, Lepu Medical also enhances the professional competencies of primary care physicians through structured training.

This approach enables the genuine promotion of AI-ECG technology at the primary care level, ensuring that primary care physicians are competent in issuing ECG reports based on AI-ECG analysis. Naturally, primary care hospitals may also adopt a tiered diagnosis and treatment model for AI-ECG; for ambulatory ECG monitoring, they can utilize Youjiali’s remote ambulatory ECG service model. These options can be selected appropriately according to the specific circumstances of each primary care hospital. Regardless of the scenario, Lepu’s AI-ECG technologies, products, and services can meet user needs and address the challenge faced by some primary care hospitals in providing ECG examinations to the broad population of patients with cardiovascular diseases.

In addition to applying its AI-ECG technology in medical institutions, Lepu Medical also plans to enter the consumer health sector, a broader market. Lepu Medical can elevate the ECG analysis and diagnostic capabilities of wearable devices to the level of professional physicians, enabling wearables (such as cardiac patches, smartwatches, and fitness bands) to truly provide medical-grade data for monitoring patients’ ECG status, thereby further promoting the widespread adoption of wearable devices.

Liu Chang stated that most ECG-related wearable devices currently on the market are single-lead ambulatory electrocardiogram (ECG) monitoring devices. These devices can typically monitor a patient’s ECG continuously for 1 to 7 days. During monitoring, the collected data is transmitted in real time to the user’s smartphone for basic computational analysis, providing simple heart rate measurements and calculations. While some products offer more complex arrhythmia analysis, the reliability of such analyses remains low due to technical limitations inherent in traditional ECG analysis algorithms. Consequently, these features provide limited clinical value to users and may even cause confusion or misdirection due to erroneous information.

Liu Chang stated that Lepu Medical already has multiple wearable electronic products that have obtained or are applying for certifications such as FDA, CFDA, and CE, gradually launching them in domestic and international markets. The Lepu Tongxin Guanjia Checkme Lite is the first consumer medical wearable dynamic ECG product to integrate AI-ECG technology and hold both cFDA and FDA approvals. It transmits real-time monitoring data via Bluetooth to the Lepu Tongxin Guanjia app on a smartphone. (Tongxin Guanjia is an application software for post-stent rehabilitation management, aiming to establish a service platform for post-stent recovery.)

This platform provides users with a range of high-quality services, including one-stop physician consultations, medical lectures, a health marketplace, daily post-operative rehabilitation plans, and a comprehensive rehabilitation knowledge base, ensuring that patients receive professional guidance after stent implantation. The Tongxin Guanjia APP uploads real-time monitoring data to the cloud-based AI-ECG Platform for real-time ECG warning analysis. The resulting alerts are sent to Youjiali’s 24/7 on-duty physician team for review. If intervention is deemed necessary upon confirmation, the physician team will contact the patient’s designated emergency contact or attending physician, while simultaneously pushing the alert results to the user’s mobile device.

This real-time alert service is a high-value-added paid service that can help patients with severe arrhythmias promptly identify critical events. Chen Juan, Deputy General Manager of Lepu Medical, previously cited recent cases in which the AI-ECG warning system of Youjiali issued timely alerts on multiple occasions, securing precious time for emergency rescue and treatment.

Meanwhile, Tongxin Guanjia also offers another comprehensive analytical diagnostic service: uploading multi-day long-term data collected to the AI-ECG Platform cloud of Youjiali for analysis and diagnosis. After review and confirmation by a team of physicians, the report is sent to Tongxin Guanjia. Of course, Tongxin Guanjia users may opt for simple automatic analysis and diagnosis via AI-ECG without requiring confirmation from Youjiali’s physician team.

This model is currently free of charge, but the AI-ECG diagnostic results only provide a simple analytical conclusion of normal or abnormal. If users exhibit abnormalities and wish to seek medical attention, Lepu Medical will offer additional medical services, which are separate paid service items. In this way, it meets consumers' diverse needs at various levels.

In addition to traditional ECG analysis and diagnosis, AI-ECG technology can also be integrated into multi-parameter patient monitors to provide comprehensive, accurate, and rapid analytical warnings for multimodal physiological parameters, with ECG analysis serving as the core of this warning system. The Lepu AI team is collaborating with universities and research institutions in China to develop artificial intelligence-assisted diagnostic technologies based on big data from physiological signals (such as ECG, EEG, and pulse waves) and to create new service models, aiming to further extend the application of AI-ECG technology to a broader range of physiological signal monitoring and analysis. Meanwhile, Lepu Medical’s AI technology team is partnering with leading domestic AI chip manufacturers to develop next-generation AI-enabled ECG devices.

Liu Chang told VCBeat that Lepu Medical aims to establish an AI-ECG technology-centered, full-industry-chain ecosystem focused on the cardiovascular field. This ecosystem includes the AI-ECG platform software system, medical-grade static (Kaiwoer) and dynamic (Youjiali) ECG hardware products, the network analysis service platform (Youjiali), physician analysis client, wearable devices, multi-parameter monitoring systems, and Tongxin Guanjia, among other products. It provides real-time, accurate, medical-grade preventive screening, monitoring, and diagnostic services for cardiovascular diseases to individuals undergoing home-based rehabilitation and those at potential risk of heart disease.

After more than six months of real-world clinical testing, Lepu Medical’s AI-ECG ECG-assisted diagnostic system has reached the proficiency level of professional physicians, and in certain complex diagnostic scenarios, it has achieved expert-level performance. The AI-ECG technology will provide a simple and effective electrocardiogram (ECG) examination method for the vast population of patients with cardiovascular diseases, enabling them to access Lepu Medical’s AI-ECG analysis and services anytime and anywhere.