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ECG Equipment

Moving beyond Holter ECG

Advanced technologies as AI and wearables are viewed as the future of ECG, and appropriately so, given continual regulatory changes, public interest, and R&D innovation. Furthermore, the cardiac issues associated with Covid-19 continue to support the need and importance of ECG in diagnostic decision-making.

Cardiovascular diseases account for an estimated 31 percent of all deaths worldwide. As a diagnostic tool, ECG has been around for a long time, and penetration of these systems in hospitals is very high. Despite its established nature, the market continues to evolve with new devices, including ECG monitoring systems at healthcare facilities; event monitors for subacute patient monitoring, which patients carry with them to record heart rhythm for short periods of time; implantable loop recorders that are surgically inserted into patients and can record heart rhythms for an extended period of time; and telemetry and ECG data-management solutions.

Innovation in healthcare technology, particularly around diagnostic ECG, continues to change how cardiovascular disease is diagnosed, monitored, and treated. Global demand is also driving growth in the ECG market, which is expected to maintain a compound annual growth rate of 6.16 percent and reach USD 7779 million by 2026, from USD 5769 million in 2021, according to Market Data.

In addition, the penetration of ECG monitors into different departments has resulted in the growing demand for ECG data-management solutions for collecting data and streamlining report generation. Many vendors are, therefore, adding an ECG data-management component to their other IT products in an effort to increase the competitiveness of their technologies. Using this type of bundling solution, just one purchase eliminates the need to acquire a stand-alone ECG data-management solution, and limits sales of ECG data-management solutions.

Resting ECG systems are ruling with the market’s highest shares, whereas stress ECG systems are growing at a higher rate since the past few years. Increasing stress levels, especially among the young population across the world, is pushing demand. Also, the growing consistency of patient’s visits to the hospital is ascribed to outshine the growth rate of the market.

By product type, 3–6 lead type ECG devices are dominating the market. Rising knowledge over manufacturing various devices with advanced technology is leveraging demand. Furthermore, the market is fueled by increased favorable conditions offered by the government.

The hospital sector is gaining traction over others. Increased construction of hospitals and a growing number of patients globally is pushing demand for this segment. Implementation of portable devices in ambulatory services is also one factor for the market to grow, as it can save many people suffering from cardiac arrest before reaching the hospital.

Patients are also becoming more empowered to monitor and track their own health, and as products and services are increasingly integrated with cloud interfaces and electronic health record (EHR) systems, diagnostic ECG technology is evolving to help them do so.

Increasing the geriatric population base, improving healthcare infrastructure, and supporting reimbursement policies are expected to impact the market growth rate positively. The advancement of technology and the introduction of remote wearable devices have helped the market growth. Developing nations witness high growth opportunities compared to developed countries because the market of developed nations is almost saturated. Developing nations often have favorable government policies, increasing healthcare expenditure, and mostly untapped potential markets, which will be the reasons for a lucrative positive growth during 2021 to 2026.

Technological advancements in communication, low-power circuit design for safer ECG devices, along with portability features, lower power consumption, more accuracy, and capacity to incorporate the latest diagnostic features are the major factors driving the growth of the market. An increasingly aging population and growing incidence of lifestyle diseases are also fueling the development of the global diagnostic ECG market.

Technological advancements and emerging trends

Dr Arathy R
Senior Design Engineer, Advanced Technologies, Research and Development,
Skanray Technologies Limited

The electrocardiogram (ECG) is a ubiquitous tool in clinical medicine that has been used by cardiologists and non-cardiologists for years. ECG monitoring provides a window into the structural and physiological condition of the heart, as well as provides valuable diagnostic signs for systemic conditions.

Recent researches and trends demonstrate the inclination of ECG monitoring toward wearable and wireless systems, which can even be combined with advanced computing technologies and artificial intelligence (AI) tools to enable better diagnosis. Such ECG monitors offer potential applications in home telecare and ambient assisted living to monitor the aged population living at home. Further applications of continuous ECG recording, embedded in armchairs, have been studied recently, developing capacitive electrodes and conductive fabrics. The telemetry and communication systems’ advancements have enabled the processed data transfer directly to the hospital server or smartphone for improved healthcare service. The wearable ECG monitors have potential applications in sports medicine, fetal ECG monitoring, ambulatory monitoring, and continuous monitoring of patients with hypertension, cardiovascular diseases, and surgical interventions. The wireless ECG system ensures the user’s freedom of movement and performs their everyday activities, which otherwise would be hindered due to wires and bulky instrumentation. In addition, the development of AI-based algorithms for automatic ECG classification and its artefacts can reduce the misdiagnosis problems and the need for the live presence of doctors.

Researchers on textile electrodes enhance the naturalness and comfort perception without skin preparation. Thus, avoiding skin irritation due to the adhesive materials would significantly reduce patient discomfort and may be adopted in clinical applications and commercial systems in the near future. Also, extensive research has been carried out in non-clinical applications like wrist-worn smartwatches that monitor basic cardiac parameters. This single-lead ECG in smartwatches, capable of detecting atrial fibrillation, has shown a strong correlation with a standard three-lead ECG system, demonstrating its potential opportunities for cardiac disease diagnosis.

The technological advancements and product innovations in the development of ECG devices are likely to propel market growth. Therefore, ECG will remain a vital tool in the diagnostic cardiology toolbox, and its presence is expanding across inpatient, outpatient, and home settings.

However, unstable reimbursement regulations, high cost of devices, and economic instability are the major factors hindering the growth of the diagnostic ECG market.

The global diagnostic electrocardiograph market is led by North America since the past decade and stays in the same position throughout the maximum timespan. Increasing revenue in almost every country is magnifying the growth rate of the market in this region. Quick adoption of the latest technologies is another factor making the market share to expand. The Asia-Pacific and Europe are following North America in accounting for the highest shares of the market by increasing population and growing support from the government by launching reimbursement schemes in favor of the ordinary people broadening the demand of the market in these regions.

Key players operating in the global diagnostic ECG market are GE Healthcare, Medtronic, Inc., Philips Healthcare, BPL Ltd., Cardiac Science Corp., Fukuda Denshi Co., Ltd., Spacelabs, Healthcare, Inc., Mortara Instrument, Midmark Corp., Mindray Medical International Ltd., Nihon Kohden Corp., Scottcare Corp., Schiller Ag, Welch Allyn Inc., and Cardionet.

Vendor update. In November 2021, Philips signed an agreement to acquire Cardiologs, a France-based medical technology company focused on cardiac diagnostics using AI and cloud technology. Cardiologs will further strengthen Philips’ cardiac monitoring and diagnostics offering with innovative software technology, ECG analysis, and reporting services.

In August 2021, Nihon Kohden acquired Advanced Medical Predictive Devices, Diagnostics and Displays (AMP3D). AMP3D offers a wide range of clinical predictive algorithms and a software-as-a-service (SaaS) platform. Nihon Kohden is planning to incorporate the CoMET software into its healthcare ecosystem.

The Indian ECG equipment market in 2021 is estimated at ₹169.16 crore, at 30500 units, a 12.4-percent increase by value and an 18.7-percent increase by quantity over 2020. With a limited number of vendors offering single channel, it is the very price-conscious buyers in selected geographical areas as New Delhi and East Gujarat that are buying single-channel machines. The price differential between 6-channel and 12-channel has been narrowing. As a result, the majority of customers are opting for the 3-channel models, while the discerning customers for the 12-channel systems. The combined share of 3-channel and high-end systems is 92.56 percent by value and 81 percent by quantity.

The high-end segment saw a 12-percent increase by value and quantity, and the market is estimated at ₹122.08 crore and 14,963 units. Within this segment, it is the 12-channel that dominates with a 71.6-percent share by value and 89.8-percent share by quantity.

The Covid-19 outbreak not only brought the economy to a standstill, but also brought to light inadequacies in health systems, thereby energizing interest in technologies that could accelerate patient outcomes where physical initiatives alone would not suffice. The pulse of the Digital Health ECG has dramatically picked up since 2019 across key areas like AI, telehealth, medical devices, mental health, digital therapeutics, Omics and health IT, with funding surpassing the 2020 total by 27 percent as per CBInsights data. India’s digital health ECG showed a 41-percent increase in funding year-on-year. With key funding in digital health having grown, the overall India digital healthcare market is expected to reach USD 5 billion by 2023, growing at a CAGR of 39 percent.

Major vendors* in Indian ECG equipment market – 2021

Tier I BPL and GE
Tier II Schiller, Philips, and Contec
Tier III Mindray, and Edan
Tier IV Nidek, Allengers, Bionet, Mortara, and RMS
Others Skanray, Nihon Kohden, Nasan, Medikit, Forest, Silverline Meditech, and regional brands, Omron (recent launch)
*Vendors are placed in different tiers on the basis of their sales contribution to the overall revenues of the Indian ECG equipment market.
ADI Media Research

The biggest advancement in ECG systems in recent years has been the movement to greater interoperability and digital formats. But other technologies are beginning to be integrated into ECG systems, such as aids to properly place leads, artificial intelligence (AI), and ways to extract additional information from ECGs to increase diagnostic value. Here are the top ECG trends for 2022 to help one better understand and anticipate changes that could profoundly influence – and change – current practices.

Although the market for ECG monitoring devices and solutions is well established, changes in device capabilities, customer demands, and reimbursement continue to reshape the landscape.

Wearable technology continues to weave itself into healthcare. Many medical device manufacturers are seeing growing demand for wearables as patients demand less restrictive ways to monitor their health. Convenience is also key as wearable devices can help physicians continuously monitor at-risk patients outside of a healthcare facility.

Ambulatory ECG technology, such as Holter monitors, offer high-quality data acquisition over time, allowing doctors to see trends and identify problems more quickly. New ambulatory ECGs are smaller and more comfortable, and some feature custom apps that guide patients through the hook-up process with visual guidance for lead placement. Additionally, certain types of ambulatory diagnostic ECGs can be easily integrated with other systems, such as telemetry or IT, to help share information, store data, and ensure patient privacy.

In the coming years, all types of ECG data will likely need to be integrated into ECG management systems to allow for a complete picture of the patient’s cardiac history. Now that the technology exists and is proliferating, the question is how and where to integrate this data into the patient record.

The increasing adoption of wearable technology across the healthcare sector is likely to drive the global wearable cardiac devices market share. In addition to the rising adoption, the rising demand for the use of non-invasive devices is also expected to push product adoption over the coming years. The latest wearable devices, which come as skin patches, are non-invasive, lightweight, and small in size. Owing to these characteristics, the patients do not have to endure implantation procedures to obtain the capability to record their cardiac parameters continuously. The wearable cardiac devices market is set to grow from its current market that was valued at more than USD 2 billion in 2021 to USD 6.2 billion by 2026, according to a new research report by Global Market Insights. Implementation of wearable cardiac devices over bulky and traditional monitoring devices is slated to proliferate at a rapid pace owing to the need for continuously monitoring patient’s heart rate, ECG, and other indicators to avoid treatment delays for conditions, such as arrythmias, thereby leading to vast product prominence. However, stringent government regulations on device adoption and issues with patient privacy and data security are likely to hinder the wearable cardiac devices market dynamics over the projected timeframe.

FDA-approved ECG smartwatches. While the FDA approval race for ECG-capable smartwatches began in 2018 with the Apple Watch – and later intensified with three other approvals in 2020 and 2021 – the year ahead could be the most active one yet. This is thanks to two emerging developments in the wearable space – positive public sentiment, which enables widespread user adoption, and advancements that give the technologies more clinical legitimacy.

On the consumer side, buzz related to ECG-capable smartwatches has catalyzed public interest, particularly through wearables’ inclusion on 2021 holiday gift guides. Aesthetic upgrades, such as those seen with the FDA-approved Withings ScanWatch, make health wearables seem less like medical devices and more like stylish accessories.

Clinically, ECG smartwatches are becoming more advanced thanks to algorithmic innovations. In the future, such advancements could boost sensitivity and help to identify atrial arrhythmias that other platforms, such as the Apple Watch, may miss. Moreover, wearable manufacturers are increasingly requiring physician involvement, and while one consumer group cited that as a con, it most certainly has its clinical advantages with respect to the future of ECG.

Artificial intelligence. Predictive AI algorithms are already being used in healthcare facilities nationwide, but these systems primarily utilize mobile cloud computing (MCC) models. As such, data transmission costs are climbing, and providers with time-sensitive needs may be faced with disconnection from core networks, latency issues, and bandwidth variations. Together, these problems could dramatically affect the likelihood of positive patient outcomes.

Dr Sameer Gupta
Director, Cardiac Cath Lab,
Metro Group of Hospitals, New Delhi

As a diagnostic tool, ECG has been around for a long time and its use is ubiquitous. An ECG continues to remain the first test ordered by cardiologists across the world and remains the gold standard for diagnosis of a myocardial infarction (heart attack) and abnormal heart rhythms (arrhythmia).The technology has not evolved from the standard ECG machines hooked to a patients to new devices like event monitors for sub-acute patient monitoring; implantable loop recorders that are surgically inserted into patients and devices that can record heart rhythms for an extended period of time.However, the big change has been in the wearables, i.e., smart watches. We now have a single-lead ECG available literally in our hands to detect any abnormal heart rhythm. It is only a matter of time before we will have a complete 12-lead ECG system available in similar devices.

AI systems are beginning to transition away from MCC models in favor of paradigms with greater availability and reduced latency, such as:

  • Edge computing, which occurs directly on the devices to which sensors are attached or on gateway devices that are physically close to the sensors
  • Fog computing, which acts at the local area network level and includes bigger devices, such as PCs and local servers

As technology advances, AI-enabled ECG may provide better real-time evaluation of data using quality assessment algorithms embedded directly in edge devices. Other algorithms may be used by AI systems to identify specific cardiovascular issues, as a Circulation: Arrhythmia and Electrophysiology study exhibited with left ventricular systolic dysfunction. According to preliminary investigational data, AI systems of this kind often outperform other diagnostic methods.

ECG market leading vendors move toward vendor neutral interfaces. One of the big issues for larger hospitals or healthcare systems several years ago was the lack of interoperability between ECG systems and ECG management systems because many operated using proprietary programing. In the last few years, many vendors have moved toward using open platform standards that are easier to interface with other vendors’ technology, including use of DICOM format waveforms and HL7 IT interfaces.

The main diagnostic ECG market is made up of 12-lead resting ECG systems. This is followed by stress ECG systems and then the remote cardiac monitor segment, which includes Holter monitors and cardiac event monitors. Today, all of these devices should be able to integrate into a central ECG management system or they will face replacement.

Even more Covid-19 considerations. Another year of Covid-19 has added to cardiologists’ understanding of the disease’s impact on the heart muscle. Importantly, 2021 research corrected an earlier hypothesis that the SARS-CoV-2 virus directly damages the heart. Instead, the heart may be a bystander of injury, according to the American College of Cardiology (ACC).

For 2022, this discovery has a bearing on the workup of patients with underlying heart conditions as well as those without them. For the former group, ECG will continue to be a critical tool, especially given the need to corroborate high troponin values with waveforms or imaging. For patients without known underlying heart conditions, the potential long-term cardiac effects of a previous Covid-19 infection will continue to validate surveillance in this growing group.

Additionally, uncertainties surrounding future variants in 2022, such as the omicron variant, which is currently under evaluation, could impact cardiac monitoring and interventions, especially if vaccine immunity does not hold up to these possible mutations. For example, the delta variant more than doubled the risk of hospitalization, compared to the alpha variant, and was particularly concerning for people with underlying diseases, including cardiovascular disease.

Growing confidence in remote cardiac care. As the pandemic continues increasing the need for virtual care, the intersections between telehealth and cardiology will become more prominent in 2022.

For instance, telehealth has been critical to remote cardiac monitoring, which is gaining ground thanks to algorithmic innovations in AI. As with the smartwatches, these improvements could support significantly better predictive values and sensitivities of ambulatory ECG devices, potentially helping to boost clinicians’ confidence in at-home surveillance.

Notably, the broadening of telehealth and expanding access to care will continue to be important healthcare themes in 2022.

Many significant advances and discoveries were made in 2021, and 2022 will likely bring even more in the areas of wearables, remote care, and Covid-19. ECG will continue to be an important diagnostic tool in cardiology, and its use is becoming more ubiquitous in inpatient, outpatient, and home settings.

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