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ECG Equipment

A new era of cardiac monitoring

A new era of consumer-centric health has begun, bringing great future benefits to preventing, diagnosing, and treating cardiovascular diseases. With further sensor and computer technology development, wearables will process more complex functions and become an integral part of cardiovascular medical practices.

Over the last decade, cardiovascular diseases (CVDs) have been the leading cause of death globally. Evaluation and interpretation of ECG signal, an efficient aiding tool, has become a major goal in current research to identify and mitigate risky cardiovascular conditions. The ECG signal, using signal-processing techniques, ranging from traditional to machine learning approaches and its sub-branches, such as deep learning are used for the early detection and diagnosis of cardiac conditions and arrhythmias. There has been a trend over the past decade toward smaller, more compact, mobile ECG monitoring systems.

The transition to more interoperable and digital formats has been the biggest development in ECG systems in recent years. Other technologies are starting to be incorporated into ECG systems, such as tools for placing leads correctly, artificial intelligence, and strategies for extracting more data from ECGs to improve diagnostic value.

With the growing interest in data and the trend toward value-based care, the healthcare industry is at a turning point, and the role of technology and digital solutions is poised to become important.

Indian market dynamics
The Indian ECG equipment market in 2022 is estimated at ₹223.8 crore, at 32,990 units, an 8-percent increase by quantity and a whopping 32-percent increase by value over 2021.

With the price differential between 6-channel and 12-channel narrowing, in fact there is barely any price difference now, there is a distinct shift in the market toward the 12-channel machines.

The price conscious buyer is going in for a 3-channel unit and the discerning buyer for the 12-channel. The single-channel segment is seeing a steady decline year on year.

Price is no longer the sole determinant when making a purchase. Features, reliability, warranty, etc., are given due weightage.

There has been no major technology enhancement for the last three to four years. Most ECG systems now have greater interoperability and digital formats. And technologies as aids to properly place leads, artificial intelligence (AI), and ways to extract additional information from ECGs to increase diagnostic value are integrated into ECG systems.

The year of 2022 has seen continued efforts on part of the government to streamline the regulation of medical devices in India. Since 2020, all medical devices are regulated in India, and this is in the process of being implemented in a phase-wise manner. This year also saw the introduction of a new law – the Draft Drugs, Medical Devices and Cosmetics Bill, 2022 (Draft Bill) – which is proposed to replace the existing Drugs and Cosmetics Act, 1940 (D&C Act). The Draft Bill is a culmination of efforts of the government to regulate medical devices independently from drugs in India. Inter alia, it proposes the creation of independent authorities and boards to take decisions on regulation of medical devices; separate provisions for licenses and violations; clinical investigations and marketing approvals for devices, etc. The Indian manufacturers are expecting the announcement by October 2023.

Global market
The global ECG equipment market is estimated at USD 5.6 billion in 2022, expected to grow at a CAGR of 7.4 percent to reach a valuation of USD 12.15 billion by the end of 2033, according to Persistence Market Research.

ECG resting system segment led with a market share of 55.4 percent in 2022. Real-time tracking and perception of heart electrical signals are some of its capabilities. They are suitable for a variety of patients and clinical requirements.

Several market players are focused toward developing advanced ECG systems. However, the holter monitors segment is expected to witness considerable growth over the next 10 years, due to increasing demand for the detection of cardiac arrhythmias, along with the diagnosis of patients suffering from cardiac arrhythmias. In addition, the utilization of holter monitors has been extended into quantification of arrhythmias, evaluation of the antiarrhythmic therapy, and analyzing prognostic aspects of the arrhythmias.

The 6-lead ECG is expected to record the fastest growth. The domination of this segment is foreseen to propel the growth of the market to considerable heights over the next 10 years. To make a precise diagnosis regarding the cardiac disorders a 6-lead ECG becomes very important for the healthcare centers. Clinicians can make an accurate diagnosis as they have a clear view of the interior condition of the heart. The 12-lead ECG recorded considerable growth too.

North America ECG market in 2022, and this trend is expected to continue. Increased healthcare expenditure and large geriatric population base are key drivers. With increasing penetration of the wearable ECG devices in the region, the Asia-Pacific region is expected to register the highest CAGR of 10.2 percent from 2023 to 2030.

Indian ECG equipment market – 2022
Leading players*
Tier I Tier II Tier III Tier IV Others
BPL and GE Schiller and Philips Mindray, Nihon Kohden, and Comen Allied, Skanray, Allengers, Nidek, Bionet, Mortara, Contec, Edan, and RMS Nasan, Medikit, Forest, Silverline Meditech, Omron, and regional brands
*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

Overall, ECG devices market sales account for 69.1 percent of revenue share in the global cardiac monitoring devices market, valued at USD 8.1 billion in 2022.

The key players include Ambu A/S, Baxter International Inc., BPL Medical Technologies Private Limited, Fukuda Denshi Co. Ltd., Johnson & Johnson, Koninklijke Philips N.V., Medtronic Plc., Nihon Kohden Corporation, Schiller AG, and Shenzhen Mindray Bio-Medical Electronics Co.

Research update – Contactless ECG monitoring
More than 100 years after the technology was first developed, ECG remains the gold standard for measuring electrical activity of the heart. However, an ECG currently requires the attachment of electrodes to a person’s skin. Even the latest consumer technologies like the Apple Watch require the user to touch the device’s protruding digital crown with a finger, which forms a circuit across the user’s body, thereby enabling the measurement of electrical signals across the heart.

Technological advancements and emerging trends

Biswajit Pradhan
National Product Manager,
Schiller Healthcare India Pvt. Ltd

In recent years, there have been significant technological advancements and emerging trends in ECG equipment, improving the accuracy, speed, and ease of use of these devices, These include:

Wireless connectivity. Many ECG devices are now equipped with wireless connectivity. This is particularly useful in remote patient monitoring allowing healthcare professionals to monitor the patient’s heart activity in real-time and detect any potential issues, such as arrhythmias or cardiac arrests, that may require immediate intervention. This information can be transmitted wirelessly to a receiving device as a smartphone or tablet.

Portable and handheld ECG devices. Portable and handheld ECG devices are becoming increasingly popular, particularly in point- of-care settings such as emergency departments and ambulances. These devices are compact, lightweight, and easy to use, making them ideal for quick and accurate assessments.

AI and ML. Artificial Intelligence and Machine Learning algorithms are being used to analyse ECG data and provide automated interpretations. These algorithms can identify patterns and abnormalities in the data that might be missed by human clinicians, improving diagnostic accuracy. An example of this is the AI that is used specifically for athletes using the Seattle Criteria, which takes into account lower resting heart rates and increased heart rate variability of athletes, in order to provide more accurate ECG interpretations.

Wearable ECG technology. Wearable ECG devices are becoming more common, and many are designed to be worn continuously for extended periods, allowing for long-term monitoring of heart function. These devices are typically small, discreet and comfortable to wear, making them ideal for patients who require ongoing monitoring for many days.

Higher sampling frequency. ECG signals are small in amplitude and occur very rapidly, therefore, it is crucial to sample ECG signals at a high frequency to accurately capture these fast and low-amplitude signals, allowing for a more accurate and precise representation of the ECG signals and providing more detailed information for interpretation. Moreover, a high sampling frequency enables the detection of high-frequency components in ECG signals, such as QRS complexes, P-waves, and T-waves, which are vital for accurate interpretation of ECGs.

However, researchers in China have reported the invention of a novel ECG technology that uses millimeter-wave radar and AI to infer an ECG signal, making the system completely contactless. Should the researchers’ initial promising results bear out, the millimeter-wave tech could inspire new applications, based on a reliable and uninterrupted stream of heart health data.

One limitation, however, is that the new approach is less accurate when a patient is randomly moving,

Nevertheless, researchers see a lot of benefits in continuous, contactless ECG monitoring, and the team is seeking to commercialize their approach. They plan to launch a product for in-home healthcare, where the elderly at high risk of heart disease require comprehensive status monitoring.

Technology trends
Some of the most recent advancements:

Wearable tech is changing the game for cardiac care. Fitness watches have been equipped with heart-rate sensors and can detect the beat of the heart, but not much more. These sensors work by using a flashing LED that penetrates the skin and can detect blood flow. So far, a clever algorithm took that information and used it to measure heart rate – useful in general, but not particularly accurate in terms of medical measurement. Today, however, new sensor technology has brought ECG capabilities to many devices, including offerings from Apple, Fitbit, and Samsung. These devices are equipped with ECG sensors that are significantly more accurate. The leading brand in this segment, Fitbit, claims that their ECG app software algorithm can correctly identify people with atrial fibrillation 98.7 percent of the time.

Technological advancements of ECG systems

Aditya Kohli
CFO and Director-Sales,
Allied Medical Limited

The resting electrocardiogram (ECG) has been used as a basic cardiac diagnostic for a century, and while the premise remains the same, testing systems are evolving to meet today’s technology demands. This includes increased mobility, ease of use, streamlined workflow and interoperability so data can easily be interfaced with electronic medical records. There has been a trend over the past decade toward smaller, more compact, mobile ECG monitoring systems.

Allied Medical Limited (AML) provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in information technologies, medical diagnostics, patient monitoring and manufacturing capabilities is helping clinicians around the world re-imagine new ways to predict, diagnose cardiac diseases, so the patients can live their lives to the fullest.

These days, ECG solutions come with interpretation algorithms as a standard feature. It uses gender- and age-specific criteria to provide a virtual second opinion for resting ECG interpretation. ECG machine have been simplified to ease workflow that includes simplified step-by-step operation, touch-screen facility, alphanumeric as well as virtual keypads in some models and better connectivity with ECG management systems, HL7, HIS and electronic medical records (EMRs). Integration component to Hospital has become increasingly important as it enables paperless healthcare and the free flow of all patient data between departments, hospitals and referring physicians. One advantage of paperless ECG review through an electronic ECG management system is the ability to access ECGs and enable remote viewing and reporting outside of the traditional workstation. Most modern healthcare providers offer remote, anywhere Web-based access to the ECG management system. This functionality includes access to ECGs and fully enabled reporting functions at home or anywhere in the hospital or clinics where a cardiologist finds some time to read cases.

Nowadays, ECG solutions offer an array of file formats for ECGs, including DICOM, XML, JPEG, PDF etc. Previous years ushered in many new developments and discoveries, and the coming years will undoubtedly bring additional insights concerning ECG solutions as it will remain a vital tool in the diagnostic cardiology toolbox, and its presence is expanding across inpatient, outpatient, and home settings.

According to a study published in Trends in Cardiovascular Medicine, these claims hold up surprisingly well, with the Apple Watch algorithm producing results with 95.5 percent sensitivity. Even the FDA is on board, giving the Apple Watch Class II FDA approval for over-the-counter ECG detection.

Indeed, the promise of wearable tech for the future of cardiac care is immense. By putting medical-grade technology into the hands of the masses, there is a significant opportunity to not only detect medical issues before they occur but to also collect and analyze vast amounts of health-related data at a scale that has never been seen before. The promise of the IoT for health-related issues is strong. Armed with this data and equipped with modern artificial intelligence and big-data-processing capabilities, doctors can explore heart-function data in vast new ways. With connectivity solutions for medical needs rising to keep up with the demands of the MedTech industry, the future of connected health-care solutions looks brighter than ever.

Integration of new technologies. Another area is lead placement aids, artificial intelligence, and information extraction. Lead placement aids help healthcare professionals to properly place leads, while AI can be used to analyze ECG data, leading to improved diagnosis and treatment. Information extraction enables the extraction of additional information from ECG to increase its diagnostic value.

Technological advancements and emerging trends

Biswaroop Chakrabarti
Scientist – Advance Technology & Application,
Skanray Technologies

Electrocardiography (ecg) will always be important in diagnostic cardiology, with its presence expanding across hospital and home settings. Besides the traditional 12-lead resting ECG, stress ECG and remote cardiac monitoring (including Holter monitoring) systems, there is a very visible trend in miniaturising ECG and ubiquitous deployment (e.g., ECG-equipped smartwatches). Another set of newer technological advancements strives to improve diagnostic value, e.g., novel signal processing and clinical decision support. These advances encompass algorithms and device technological improvements. The final goal is to improve interoperability and allow caregivers’ data access on the move and different platforms.

In the last few years, there has been an explosion in non-standard/consumer-grade ECG, ranging from wireless ECG systems, ECG enabled stethoscopes to handheld and wearable devices and ECG-enabled smartwatches. Some of these personal ECG devices can record up to six leads. Though arguably inferior in quality to diagnostic systems, they can provide timely alerts for life-threatening conditions when used with algorithmic interpretation. They can also potentially enrich patient health records. Flexible, 3D-printed dry electrodes that can be used with such devices have been demonstrated. Other directions to enable less experienced users to include technology to aid lead placement.

High-resolution ECG (with increased temporal sampling), multi-lead ECG and novel signal processing (e.g., wavelet analysis to detect relaxation abnormalities) are some examples of enhancing clinical value. Algorithmic interpretation and CDSS are increasingly the norms with several systems. In particular, deep neural network models trained to detect various clinical conditions have been and are being reported. Examples include MI occurrence identification, ambulatory ECG analysis, heart failure prediction, etc. There is evidence of convolutional neural networks trained on ECG and clinical datasets achieving nuanced, human-like diagnostic accuracy.

A final trend is an interoperability. ECG devices increasingly support DICOM format waveforms and HL7/FHIR allowing better integration with CPOE/EHS systems. Besides informatics interoperability, efforts to streamline device-specific standards are underway by the ISO/IEC Joint Work Group 22 as IEC/CD 80601-2-86.2. The new standard will replace disparate standards on diagnostic, monitoring and ambulatory ECG equipment, electrodes, cables, and lead wires.

ECG systems have also moved toward full digitization in recent years. Older-generation ECG systems were largely incompatible with different vendors’ cardiology reporting systems or electronic medical record (EMR) systems, with the focus being a paper printout. But now, modern ECG systems need to be IT compatible and digitally stored, to fit into the increasingly paperless hospitals that use EMRs to access patient reports and data.

To cater to the different needs of various healthcare facilities, ECG vendors offer multiple types of systems, ranging from simple, less sophisticated versions to premium systems. This allows them to address the different needs of large, busy, urban hospitals, as well as physician offices, and small remote sites. The vendors can also provide tailored solutions to each market, ensuring that healthcare facilities have access to the technology they need to provide high-quality care.

ECG equipment – Trends and expectations for the next one year over

Dr Sameer Gupta
Interventional Cardiology & Peripheral Intervention*

The next one year, the global ECG equipment market is expected to reach USD 7.5 billion, growing at a CAGR of 6.1 percent from 2020 to 2025. The increasing prevalence of cardiovascular diseases, which cause an estimated 17.9 million deaths worldwide each year, is a major factor driving the demand for ECG equipment. Additionally, the Covid-19 pandemic has highlighted the importance of remote patient monitoring and telemedicine. In India, telemedicine has witnessed a surge in adoption, with the government promoting its use for non-Covid-19 healthcare services during the pandemic.

In this context, I expect the ECG equipment industry to witness a surge in demand, especially in the private healthcare sector, as more people become aware of the importance of regular cardiac screening. There is also a growing trend toward the adoption of portable ECG devices that can be used at home or in primary healthcare centers. The global portable ECG devices market is expected to grow at a CAGR of 9.1 percent from 2020 to 2025.

Market trends suggest a shift toward more advanced ECG machines that offer better diagnostic accuracy, ease-of-use, and connectivity with electronic medical records. For instance, the use of artificial intelligence and machine learning algorithms can aid in faster and more accurate diagnosis of cardiac conditions. ECG equipment manufacturers should, therefore, focus on providing innovative and cost-effective solutions that improve patient outcomes.

As a buyer in the ECG equipment industry, my hospital intends to invest in high-end ECG machines that are capable of performing advanced analysis and interpretation of cardiac signals. We also plan to upgrade our existing ECG devices with the latest software updates to ensure that they meet the latest regulatory standards. However, cost will remain a major consideration for most buyers, especially in the government and public healthcare sectors.

In conclusion, the ECG equipment industry is poised for growth in the next one year, driven by factors, such as the increasing prevalence of cardiovascular diseases and the adoption of telemedicine. Manufacturers should focus on providing affordable and reliable devices that cater to the needs of different segments of the market, while also keeping up with the changing needs and preferences of buyers.

*The author is also Director, Cardiac Cath Lab, Metro Group of Hospitals; Director, Umkal Hospital; MD, Aurum Senior and Assisted Living,; Co-Chair, Healthcare Committee, PHDCCI and Co-Founder, Voice Of

Integration of AI. The development of AI algorithms for ECG analysis has significant implications for healthcare providers and patients alike. By analyzing ECG signals, AI algorithms can quickly detect various conditions, such as arrhythmias, cardiac anomalies, and risk of heart attacks, allowing for more timely and effective treatment. These algorithms are trained on large datasets and use advanced machine learning techniques to identify patterns and anomalies in the data. Moreover, AI algorithms can continuously learn and improve over time, becoming more accurate as more ECG data is analyzed. This technology not only improves the accuracy and efficiency of ECG data analysis but it also reduces the workload of healthcare providers. Overall, the integration of AI into ECG analysis represents a major step forward in the advancement of healthcare technology and has the potential to greatly improve patient outcomes.

The healthcare industry is experiencing a major transformation with the adoption of digital solutions and technology to improve patient diagnosis and care. The integration of ECG technology with other wearable devices is providing a more comprehensive view of overall health and wellness, while the move toward value-based care is driving the need for efficient patient care through technology and digital solutions.

The adoption of next-generation ECG monitoring technology is just one example of how the healthcare industry is evolving to meet the demands of a changing landscape. As the industry continues to transform, it is crucial to remain up to date with the latest technological developments and trends to ensure that patient care remains at the forefront of this transformation.

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