[Roundup] Those Cool Wearable ECG Devices: Do You Really Understand Them?

A 2014 report by Allied Market Research predicted that the global mobile health market would achieve a compound annual growth rate (CAGR) of 33.5% over the subsequent five years (2015–2020). The market size was valued at $10.5 billion in 2014.

In terms of mobile devices,Blood pressure monitors will hold the largest market share, followed by blood glucose meters and ECG monitors., these three types of devices will account for 71% of the mobile health device market.

Today, competition in the blood pressure monitor and blood glucose meter markets remains fiercely intense, with the diabetes and hypertension sectors enjoying strong momentum and significant investor enthusiasm. Although major investment firms have all declared the ECG market a critical strategic frontier they must capture, most companies still lack the courage or confidence to enter the fray. Faced with sophisticated and complex ECG devices, intricate and elusive ECG waveforms, not to mention their clinical significance and application scenarios, these companies can only look on helplessly at the vast cardiovascular disease market comprising 290 million patients.

What aspects of wearable ECG devices do industry insiders truly focus on? How are ECG devices categorized in the market? From a professional medical perspective, what are their respective clinical significances and application scenarios? How many ECG products are currently available on the market? Driven by these questions, the author conducted a comprehensive and professional in-depth analysis of wearable ECG devices by interviewing experts across various fields.

Classification of Electrocardiogram Devices from a Medical Perspective

Currently, there are over one hundred companies involved in the domestic mobile health market that offer ECG devices, categorized byDevice AccuracyClassification: Their products can be divided into:I. Health-Grade ECG Devices, such products do not hold a CFDA medical device registration certificate and can be used for health data recording; however, due to the lack of clinical evidence, they cannot be used as a reference for medical consultation;II. Medical-Grade ECG Devices, such products hold CFDA medical device registration certificates, and some have undergone rigorous and comprehensive clinical trial validation. They possess varying degrees of medical value and can serve as references for medical diagnosis and treatment, depending on the circumstances. Medical-grade ECG devices are further categorized into three types based on performance metrics, accuracy, clinical significance, and application scenarios:Static Electrocardiograph (ECG), Holter Monitor, and ECG Monitor, the requirements for performance metrics and accuracy of these three types of devices are progressively lower in both medical practice and standards. In other words, static electrocardiographs have the highest requirements for accuracy and performance metrics, followed by dynamic electrocardiographs, while ECG monitors have the lowest (see Table 1).
Table 1. Different Standards for ECG Monitors, Holter Monitors, and Resting ECG Machines



1. Resting Electrocardiograph (ECG)
It is primarily used for surface electrocardiogram (ECG) testing with an ECG machine under resting conditions. It has the widest clinical application and the highest diagnostic value, serving as the gold standard for diagnosing arrhythmias. It can diagnose all types of arrhythmias and most cases of myocardial ischemia and myocardial infarction, and determine the location of myocardial infarction. Static ECG machines used in hospitals are mostly 12-lead systems. Furthermore, the national medical device standard YY1139-2013 stipulates that ECG diagnostic equipment must have at least 7 leads.

Static ECG offers the highest precision and the most stringent requirements. In a multi-purpose device design scenario, it can cover and fulfill all the functions of dynamic ECG and ECG monitoring. Meanwhile, due to its high precision and large data transmission volume, it demands a higher level of R&D technical capability, which is difficult for the vast majority of wearable ECG devices on the market to achieve.

2. Ambulatory Electrocardiogram (Holter)
Also known as Holter monitoring, it is primarily used to continuously record electrocardiographic (ECG) signals over an extended period (24–48 hours) while patients engage in their normal daily activities. As an advancement and extension of standard resting ECG, it is mainly indicated for patients who experience symptoms but show no abnormalities on resting ECG. By enabling prolonged ambulatory monitoring, it captures transient and elusive paroxysmal arrhythmias, providing quantitative and qualitative assessments to determine severity, thereby guiding treatment decisions and prognostic evaluation.

Dynamic electrocardiography (ECG) has lower accuracy requirements for waveform interpretation and diagnosis compared to static ECG, placing greater emphasis on statistical analysis over extended periods. Even within this statistical framework, the acceptable margin of error is relatively large. For example, in a patient with premature ventricular contractions (PVCs), the clinical significance of the difference between 1,000 and 2,000 PVCs recorded over 24 hours is minimal. However, the distinction between 1,000 and 10,000 PVCs is substantial, as management strategies differ significantly between patients with these respective burdens of PVCs.

Due to the lower accuracy of ambulatory electrocardiography (ECG) compared to resting ECG, ambulatory ECG cannot replace the functions of resting ECG in multi-functional device design scenarios. However, if the design permits, it can cover and meet the requirements for ECG monitoring.

3. ECG Monitor
In-hospital, ECG monitors are primarily used in ICUs to monitor and provide early warnings for electrocardiographic changes in critically ill patients; out-of-hospital, they are mainly applied in remote real-time monitoring. Due to their relatively low accuracy and limited applicability, professional clinical judgment is required in monitoring scenarios. ECG monitors cannot replace or substitute for the functions of static (resting) or dynamic (ambulatory) electrocardiography.

Based on the wearing method, ECG devices can be further classified into: optical heart rate type, single-lead contact/handheld type, single-lead patch type, and standard lead type (multi-lead):

1. Photoplethysmography (PPG) Heart Rate Monitoring
Most heart rate-monitoring wristbands and smartwatches available on the market fall into this category, including the Apple Watch. Neither their underlying principles nor their accuracy meet medical-grade requirements; they are suitable only for daily activity tracking and hold no clinical reference value.

2. Single-lead contact/handheld
Specifically, adhesive electrodes are not used; instead, simulated chest leads and dual-hand leads (Lead I) are commonly employed to meet users’ needs for rapid ECG screening. Such ECG devices can detect a limited subset (10–12 types) of arrhythmias.

Manufacturers of such devices include Dimetech, Yitikang, Zhongwei Laikang, and Lifeline. Since these devices require users to hold or maintain contact with them for measurement, they only support short-term use scenarios and cannot facilitate long-term monitoring. From a medical perspective, short-term single-lead monitoring has limited clinical significance.

3. Single-Lead Patch-Type
Unlike handheld or contact-based devices, single-lead patch-style monitors with data storage capabilities are suitable for continuous, long-term monitoring. From a clinical perspective, single-lead devicesif and only if under the test scenario of continuous long-term wear (>48h)only then does it hold true clinical significance, with arrhythmia detection rates comparable to, or even surpassing, those of Holter monitoring. However, many manufacturers, even for single-lead patch devices, have not specifically designed their products for long-term wear scenarios. Either the devices rely solely on Bluetooth connectivity for real-time display, or they transmit data in real time via networks, without incorporating capabilities for long-term data recording and storage. This represents a missed opportunity to leverage the optimal performance of single-lead patch devices for long-term ambulatory monitoring.

There are numerous manufacturers of single-lead patch-based devices, including Xinshu Technology, Taikong Xinyi, Hetao Heart Patch, Haopengyou EL-191 ECG Monitor, and Palm ECG.

4. Standard Lead Configuration (Multi-lead)
To meet users’ needs for precise ECG monitoring, devices with more than seven leads deliver diagnostic results comparable to hospital-grade electrocardiographs (as stipulated in the YY1139-2013 standard, ECG diagnostic equipment must have at least seven leads). Multi-lead ECG devices (>7 leads) can comprehensively record dynamic cardiac activity, enabling the diagnosis of the vast majority of arrhythmias as well as certain cases of myocardial ischemia and myocardial infarction. In contrast, single-lead products are limited to detecting only a few types of arrhythmias. By expanding the detection rate of arrhythmias and extending its user base to include patients with coronary heart disease and high-risk populations (such as those with hyperlipidemia and diabetes), multi-lead ECG devices significantly broaden the product’s applicable scenarios and scope. This approach also overcomes the limitations of single-lead devices in specialized clinical settings, facilitating greater acceptance by hospitals and physicians, thereby enabling doctors to accurately assess patients’ conditions and provide targeted treatment plans.

However, due to the significantly higher technical barriers compared to single-lead systems, achieving a lightweight, wearable, and portable design is even more challenging. Consequently, there are few manufacturers in this space, including Dimetech, Haopengyou EL-194 ECG Machine, and Tete ECG Monitor.

According toTest Duration, ECG devices can be further categorized into: short-term rapid testing (<24 hours), long-term ambulatory monitoring (>24 hours), and real-time monitoring.

Future Development Trends of Wearable/Mobile ECG Devices
Medical-grade, high-precision ECG devices are inevitably the future trend. A truly useful, effective, and valuable wearable ECG device can completely avoid the awkward fate of being “shelved” that plagues many other wearable devices on the current market. Conversely, an increasing number of smartwatches and fitness bands on the market will face obsolescence. After all, the data metric physicians rely on for detecting and diagnosing heart disease is not heart rate, but the electrocardiogram (ECG), with higher precision being preferable. ECGs measure the electrical activity of the heart. If one merely uses a health-tracking device to monitor heartbeat patterns without examining the ECG, it is impossible to determine whether heart disease is present. At times, a rapid heartbeat is simply due to recent vigorous exercise and does not indicate a risk of disease.

Of course, even medical-grade wearable devices cannot revolutionize healthcare, as the core of medical practice still lies in hospitals and physicians. Smart wearables can only assist doctors with auxiliary treatment tasks. Therefore, beyond the framework of “hardware + ECG algorithms + apps,” how to build a highly adaptable service platform with an excellent user experience—and thereby identify the most advantageous business model—remains one of the key issues that major manufacturers must address.

Overview of the Operational Models of ECG Device Manufacturers
Unlike the traditional medical device market, wearable ECG devices primarily target home users. The key challenge for every ECG device manufacturer is to make relatively professional, complex, and difficult-to-understand ECG products accessible to households by designing solutions suitable for home use. Currently, the operational models of ECG device manufacturers in the market mainly include:1. Manufacturers focused solely on the R&D, production, and manufacturing of ECG hardware: This is a more traditional model. The ECG devices are typically all-in-one terminals with displays, lacking professional ECG analysis software and services. These devices only output waveforms without providing diagnostic results. Examples include Dimetech and Leekang.2. Manufacturers that develop both ECG hardware and employ algorithm R&D teams to create automatic analysis software: These companies pair their ECG devices with automatic analysis software featuring various functions to interpret ECG results. This approach simplifies complex professional ECG waveforms, making them easier to understand and more suitable for home users. Examples include Palm ECG and Hutao Heart Patch.3. Companies that provide not only hardware, algorithms, and software but also various ECG-based services, such as remote ECG monitoring and emergency response, as well as cardiac health management. Given the specific nature of ECG devices and cardiovascular diseases, these follow-up services are an indispensable part of the ECG market. Such companies have high requirements for comprehensive business capabilities. Current leaders in this segment are either established industry veterans or emerging technological dark horses, such as Zhongwei Laikang, Ucare, Good Friend ECG, and Heart Guardian.

A Deep Dive into Wearable ECG Devices
Having covered so much, do you still feel overwhelmed by the dazzling array of wearable ECG devices? Now, let’s move on to a practical review. We invite readers to apply their newly acquired knowledge while it’s still fresh and join the author in conducting a comprehensive and professional analysis of the most prominent and popular wearable devices currently on the market. (The following list is not ranked in any particular order.)

▼Manufacturers Focused on Hardware Production

1. Dimetai
Company: Shenzhen Dimeitai Digital Medical Technology Co., Ltd.
Website:http://www.dimetekcn.com/

2. Likang
Company: Lifecare Biomedical Technology Holdings Limited
Website:http://www.healforce.com/cn

▼Hardware-Software Integrated Vendors

3. Yitijiankang
Company: Yitikan (Beijing) Technology Co., Ltd. Secures RMB 30 Million in Series A Funding Led by Matrix Partners China
Website:http://www.etcomm.cn

Yitikan has been in operation for eight years, positioning it as a veteran among ECG device manufacturers. However, its extensive operational experience does not appear to have translated into significant improvements in its hardware offerings; both the design and performance of its products remain relatively rudimentary. The planned launch of a more accurate and professional multi-lead (12-lead) ECG monitor in 2015, intended to better serve the B2B market, has yet to materialize. This suggests that Yitikan lacks substantial technological advantages in hardware R&D. Consequently, the company has shifted its focus toward services, aiming to build a telemedicine platform based on its products to provide various solutions for end customers. Despite this strategic intent, its current service offerings are limited to online consultations conducted in partnership with Chunyu Doctor, leaving it with little autonomy. The depth and comprehensiveness of its service layout remain unconvincing. Therefore, Yitikan is currently categorized as a manufacturer without integrated services.

Fortunately, the company attracted capital investment in early 2015 and is expected to make more significant moves in 2016.

4. Handheld ECG
Company: Nanjing Xijian Information Technology Co., Ltd.
Website:http://www.mhealth365.com

As a product whose primary metric is dynamic electrocardiography (ECG), the requirement in the user manual that it be used only at rest appears somewhat contradictory. Furthermore, the necessity of maintaining a connection to a smartphone during use precludes long-term monitoring with true ambulatory significance, thereby limiting its application to short-term monitoring scenarios. Nevertheless, the interface and user experience of the Android-based automatic analysis software are quite commendable. Strikingly similar to Yitikan, Palm ECG is also expanding its downstream layout by partnering with Xingshulin to launch online consultation services.

5. Tai Kong Xin Yi
Company: Beijing Oriental Taihua Technology Development Co., Ltd. It is reported that the company completed its Series A financing round of RMB 60 million in August 2015; however, publicly available online information suggests the amount was RMB 15 million, with the exact figure remaining unclear.
Website:http://www.dftaihua.com

Similar to palm-held ECG devices, it must be connected to a smartphone via Bluetooth for real-time display during use. It lacks storage functionality, and its battery life cannot support prolonged operation (>24 hours). Consequently, it is incapable of achieving truly dynamic long-term monitoring and is therefore limited to short-term monitoring scenarios. However, Taikong Xinyi’s promotional materials claim: “Currently, Taikong Xinyi achieves an arrhythmia detection rate of 91.67%, whereas 12-lead Holter monitors do not exceed 62%.” Given the aforementioned specifications, it is implausible for a single-lead ECG device, with a significantly shorter monitoring duration than Holter monitors, to have a higher arrhythmia detection rate than Holter monitors. Furthermore, according to the author’s knowledge, Taikong Xinyi, which received CFDA certification in May 2015, is by no means as described in its promotional materials: “China's First CFDA-Certified Wearable Single-Channel ECG Monitor”, such exaggerated claims inevitably give rise to unfounded concerns.

6. Tete ECG Monitor
Tete ECG Monitor is a smart home electrocardiogram device jointly launched by Baidu DuLife and third-party hardware manufacturer Changchun Huaxun Information Technology Co., Ltd.
Company: Changchun Huaxun Information Technology Co., Ltd. / Baidu DuLife
Website:http://www.tetelife.com

For a product primarily designed for ambulatory ECG monitoring, we were unable to find more specific information on the website and in promotional materials regarding two key indicators that directly impact user experience: battery life and whether the device itself has storage capabilities.

7. Walnut Heart Patch
Company: Shenzhen Meidaer Qianhai Medical Technology Co., Ltd.
Website:www.wootop.cn

The Walnut Heart Patch features a stylish design. Although it is somewhat bulky, its volume and weight are not disclosed in the official specifications. While the device itself lacks local storage capabilities, promotional materials for the Walnut Heart Patch indicate that it achieves cloud-based storage by continuously uploading data to the cloud. If this technology proves stable and the battery life is sufficient, the Walnut Heart Patch can be said to enable long-term monitoring. However, the Walnut Heart Patch is a consumer-grade health product without any medical certification. The fundamental prerequisite for the accuracy of any analysis—whether it pertains to heart rhythm, heart rate, cardiac health, or merely exercise recommendations—is the accuracy of the collected data. If the front-end data acquisition is inaccurate and does not meet medical-grade standards, even the most sophisticated algorithms will be ineffective.

8.Hellofit
Company: Jining Zhongke Daxiang Medical Electronic Technology Co., Ltd.
Website:www.eleph.cn

Hellofit has obtained CE certification from the European Union but lacks certification from the China Food and Drug Administration (CFDA). Consequently, it is not classified as a medical-grade device in China, which may explain why its primary market is Europe. In terms of chips and algorithms, Hellofit utilizes NeuroSky’s ECG algorithms. Regardless of the industry’s varying levels of acceptance of NeuroSky’s algorithms, relying on a third party rather than developing proprietary technology for ECG algorithms—a core component of ECG devices—means that control effectively rests in others’ hands, resulting in slightly reduced flexibility and autonomous adaptability.

9. Xinshu ECG Monitor
Company: Shanghai Xinshu Technology Development Co., Ltd.
Website:www.heartbook.com.cn

Although it claims to be a medical-grade device (Class II medical device), the author found no qualification certifications for the Xinshu ECG Monitor in the database of the National Medical Products Administration. Given that the metrics it measures are limited to heart rate level and do not reach the standard of electrocardiogram (ECG) level, it should be categorized as a health-related software rather than a medical one. The data obtained can serve as a suggestive reference, but its accuracy is questionable; therefore, the analyses derived from this reference data hold limited practical value.

▼Hardware-Software Integrated Solutions + Service Providers

10. Zhongwei Laikang—A Pioneer in Remote ECG Monitoring
Company: Zhongwei Laikang Technology Development (Beijing) Co., Ltd.
Website:http://www.lifecarenetworks.com

Zhongwei Laikang is a pioneer in remote ECG monitoring, with a decade of industry experience. However, similar to Yitikang, its long-standing presence has not translated into significant hardware advantages. Compared to Yitikang’s handheld/patch dual-use single-lead product, the accuracy and applicability of Zhongwei Laikang’s handheld monitor remain open to question. The company’s strengths and focus appear to lie more in remote monitoring systems and services. As one of the earliest companies in China to launch remote ECG monitoring, it currently primarily provides services related to remote cardiac monitoring, screening, diagnosis, and rehabilitation therapy. Users utilize smart ECG monitoring devices to instantly record and transmit electrocardiograms, which are then interpreted online by more than ten full-time physicians within the company, who provide feedback within 2–15 minutes. The company also collaborates with hospitals, allowing them to select service models based on their needs—either conducting independent monitoring throughout the process or delegating monitoring to Zhongwei Laikang’s Monitoring Center—thereby ensuring optimal allocation of medical resources. Zhongwei Laikang continues to primarily serve the B2B market and does not sell devices directly to patients; instead, hospitals purchase the equipment and lease it to patients for use.

11. Ujiali—The Unstoppable Dark Horse
Company: Shandong Youjiali Information Technology Co., Ltd. secured RMB 50 million in Series B financing from Lepu Medical in March 2015
Website:http://www.yocaly.com

Founded in 2005, Ujiali surged to prominence at the beginning of 2015. Positioning itself as the No. 1 player in China’s remote cardiac monitoring sector, Ujiali claims to be the only company capable of providing professional-grade remote cardiac monitoring services to hospitals. Publicly available information indicates that Ujiali’s hardware offerings are not particularly distinctive, as they are produced through OEM partnerships. Instead, its external communications emphasize its proprietary adaptive analytical decision-making and early-warning algorithm software, along with its remote cardiac monitoring system platform. When abnormalities are detected in a user’s ECG data, the adaptive analysis and diagnostic system notifies the user, their physician, and designated family members, thereby enabling timely intervention. The service is further supported by professional data analysts on 24-hour duty, who conduct secondary reviews of anomalous data to enhance the accuracy and effectiveness of data analysis. Having completed its Series B financing, Ujiali is continuing to consolidate and expand its presence in the business-to-business (B2B) market while simultaneously preparing to enter the consumer-to-consumer (C2C) market by developing cardiac health solutions tailored for individual users.

12. Good Friends: The Understated Powerhouses with Strategic Layouts
Company: Shenzhen Zhongruiqi Electronic Technology Co., Ltd.
Website:http://www.myheart365.com

Compared with other manufacturers, Zhongruiqi maintains a relatively low-key profile. Based on currently available public information, its strategy focuses solely on collaboration with Alibaba. As a core member of the “Cloud-Based Peace of Mind Alliance,” it diligently works behind the scenes. Even though Wang Jian, CTO of Alibaba, has publicly praised the company on several occasions, there has been no extensive media coverage or PR campaigns. Founded in 2012, Zhongruiqi has experienced rapid growth. Its independently developed hardware products form a systematic portfolio, offering single-lead, 8-lead, and 12-lead devices tailored to different user groups. These devices are not only compact and lightweight (claimed to be the “smallest and lightest” among similar products globally) but also achieve the highest level of accuracy characteristic of medical-grade equipment—specifically, static electrocardiogram (ECG) precision. The algorithm team and app-plus-platform development capabilities represent one of Zhongruiqi’s greatest strengths. Within a short period, the company has developed multiple software applications, platforms, and solutions suitable for various partners and diverse population segments. Whether targeting business-to-business (B2B) or business-to-consumer (B2C) markets appears to be a flexible, opportunity-driven strategic choice.

Yet, despite such pronounced technological advantages, there has been no flood of media coverage. This suggests that the team’s weakness lies in marketing. Whether they can break the deadlock and stand out in 2016, or win the favor of capital, remains to be seen.

13. Heart Guardian: A Low-Key Powerhouse with Strategic Depth
Company: Beijing Ouqiao Century Technology Co., Ltd.
Website: Guanhu Network http://www.guanhu.net (no longer accessible)

Oubridge Technology began its transition into the medical sector in 2008; however, its Heart Guardian product was not launched until 2013. In terms of hardware, while traditional remote ECG monitoring devices from other manufacturers tend to have a somewhat bulky appearance, Oubridge’s product resembles that of Zhongruiqi, featuring a lightweight, stylish, and portable design. The difference lies in accessibility: the former can only be viewed on a computer (the “Guanhu Wang” platform, which claims to enable ECG viewing, has been inaccessible for a long time—what has happened to Heart Guardian?), whereas the latter supports multiple terminal devices for data access. Unlike Zhongruiqi, which offers diverse solutions such as real-time monitoring, manual interpretation, and daily management, Oubridge is a company focused exclusively on real-time remote cardiac monitoring. Users wearing the Heart Guardian device upload their ECG data to cloud servers in real time. When dangerous abnormalities are detected, the system can directly send notifications via phone calls to pre-registered family members and physicians, thereby providing timely warnings and alerts for high-risk users.

In summary, although the concept of ECG devices appears somewhat more glamorous than that of blood pressure and blood glucose monitors, and market acceptance will take time, their overall positive trajectory and future potential are unquestionable. The flourishing development of the domestic ECG market in China is indeed encouraging; however, the relatively high technical barriers seem to have left the capital market somewhat confused. Regardless, while 2016 is widely regarded as a “capital winter” for mobile health, spring in the ECG sector appears to be just beginning.

▶ This article is a contribution by Kelly to VCBeat. The views expressed are solely those of the author and do not represent the position of VCBeat.
Kelly, Internet Observer