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Diagnostic Electrocardiography Devices Market

The market for Diagnostic Electrocardiography Devices was estimated at $9.2 billion in 2025; it is anticipated to increase to $13.3 billion by 2030, with projections indicating growth to around $19.2 billion by 2035.

Report ID:DS1801058
Author:Debadatta Patel - Senior Consultant
Published Date:
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Life Science
Medical Device
Diagnostic Electrocardiography Devices
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Market Data
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Global Diagnostic Electrocardiography Devices Market Outlook

Revenue, 2025

$9.2B

Forecast, 2035

$19.2B

CAGR, 2026 - 2035

7.6%

The Diagnostic Electrocardiography Devices industry revenue is expected to be around $9.2 billion in 2026 and expected to showcase growth with 7.6% CAGR between 2026 and 2035. Diagnostic electrocardiography equipment is essential in modern day cardiology as it is used in nearly two thirds of the need for these devices, which is coming from hospitals and cardiac treatment centres. There is a growing demand from these places for diagnostic ECG technology to help manage patients with heart conditions and to cater for more complicated cases. In 2025 portable cardiac diagnostic equipment produced $5.97 billion. This represents a significant shift towards point of care, mobile cardiac diagnostic technology that allows for the quick diagnosis of irregular heartbeat, monitoring of patients from a distance and efficient care delivery. Technological advancements coupled with increasing use of telemedicine and the integration of ECG readings into computer aided clinical diagnosis systems are increasing the importance of these devices in both short and long term heart disease treatment.

A wide variety of diagnostic electrocardiography machines are available, encompassing ECG machines for resting conditions, those which are stress ECG machines, Holter monitors, event monitoring equipment plus portable ECG devices. Care delivered at the bedside is enhanced through features including secure connectivity with hospital ECG solutions and cardiology systems, automated interpretation tools, high definition waveform display and the ability to acquire and store multiple cardiac signals. The devices use is widespread in numerous applications including pre and post operative assessment, cardiac disease follow up, routine screening for heart disorders, ischemia and arrhythmia management. These uses take place in various locations which include home care, ambulatory clinics, cardiac facilities, emergency medical services and hospitals. Factors such as small wearable devices, smartphone use for patient monitoring from a distance, cardiology telemedicine processes with the support of AI and cloud based analysis of heart rhythm data, are boosting demand for the market.

Diagnostic Electrocardiography Devices market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2025-2035
Diagnostic Electrocardiography Devices Market Outlook

Market Key Insights

  • The Diagnostic Electrocardiography Devices market is projected to grow from $9.2 billion in 2025 to $19.2 billion in 2035. This represents a CAGR of 7.6%, reflecting rising demand across Routine Cardiac Check-ups, Preventive Cardiology, and Intraoperative Monitoring.

  • Major manufacturers of the global patient monitoring market include Koninklijke Philips N.V., Medtronic and GE Healthcare, who are responsible for the competitive landscape of the market.

  • The United States and Germany together form the most prominent market for diagnostic electrocardiography devices. In the forecast period from 2025 to 2030, the US and Germany are expected to see growth in the compound annual rate of 4.9 to 7.3% .

  • The highest growth rates will be observed in the emerging markets of South Africa, India and Brazil, with growth rates ranging from 8.7% to 10.5% per annum.

  • The diagnostic ECG devices market will grow due to the shift towards portable devices by $973 million by 2030.

  • Diagnostic electrocardiography devices are expected to generate an extra $9.9 billion by 2035, from 2025. A significant portion of the growth in the electrocardiography devices market is due to Primary Care Centres and Cardiac Centres. These centres are anticipated to hold a larger share of the market for these devices.

  • The global diagnostic electrocardiography market, which has been adversely affected by the increasing number of cardiovascular disease cases, is expected to grow 108% between 2035 and 2025.

diagnostic electrocardiography devices market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Diagnostic Electrocardiography Devices - Country Share Analysis

Opportunities in the Diagnostic Electrocardiography Devices

At clinics serving rural and semi urban India, there are also relatively few people who are using electrocardiograph. Portable, low cost ECG devices are available to make it possible for village health workers to conduct large scale cardiac screening at the village level. In addition, partnerships with public health programs could help realise the markets potential. Additionally innovative financing methods for medical equipment could be beneficial. Portable devices for frontline primary care are expected to develop most rapidly when they are combined with telecardiology services and a centralised ECG analysis computer package, so that remote over reading can be facilitated.

Growth Opportunities in North America and Asia Pacific

The major end users of diagnostic electrocardiography devices in North America are well established hospitals with a large number of cardiology departments. These institutions have the resources and expertise necessary to provide high volume ECG services, including stress tests and Holter monitoring. Major potential exists for hospitals and cardiac treatment centres to update existing ECG diagnostic systems to cloud based, connected systems which are integrated with patient medical records and have the capability for AI assisted ECG monitoring for arrhythmia diagnosis. The market is becoming more competitive with the presence of traditional providers of multi modal imaging and monitoring systems, smaller regional companies which focus on producing medical devices used in hospitals, and companies which specialise in digital health. The regions cardiology market is driven by a high incidence of cardiovascular disease. Guidelines from cardiology societies in this region stress the importance of early ECG based risk assessment. The demand for ECGs is being driven by the rapid expansion of cardiology services outside of hospital. Furthermore, the insurance companies in the region are pushing the movement of routine ECG tests to both ambulatory surgery centres and primary care centres.
Asia Pacific diagnostic electrocardiography market growth is influenced by a dual distribution structure in which urban hospital groups and specialist cardiology centres serve a high end market whilst primary care and community health clinics drive lower cost device sales. Hospitals in major cities are key users who drive adoption of cardiac monitoring systems with high capacity. This is achieved through the use of ECG machines that can connect to a network. These institutions also rely on portable ECG devices to manage a high volume of patients. Key opportunities include the local manufacturing of affordable diagnostic electrocardiogram devices which can be sold in emerging markets, the deployment of point of care ECG monitors in rural region's as well as partnerships with government programmes that focus on early arrhythmia detection and high blood pressure management. The market contains companies such as global medtech businesses along with regional brands that aggressively market cardiac monitors at a lower cost. Also featured are start up health businesses which integrate ECG information into mobile health apps and also in systems which monitor patients remotely. Key factors in the growth of the market are the increasing incidence of cardiovascular diseases in ageing and urban populations, increased coverage of health insurance, government investment in the development of healthcare infrastructure and initiatives to use digital health technologies.

Market Dynamics and Supply Chain

01

Driver: Increasing Burden of Cardiovascular Diseases and Rising Demand for Preventive Heart Monitoring

The diagnostic electrocardiography devices market is also strongly driven by the growing global burden of cardiovascular diseases (CVDs) and the increasing emphasis on preventive heart monitoring. CVDs remain the leading cause of mortality worldwide, with conditions like arrhythmias, myocardial infarction and heart failure becoming more prevalent due to aging populations and lifestyle risk factors such as sedentary behavior and diabetes. This rising disease burden fuels demand for accessible, reliable ECG diagnostics in routine check‑ups and clinical evaluations, prompting healthcare providers to invest in advanced resting and ambulatory ECG systems. Simultaneously, heightened awareness of preventive cardiology is also prompting both clinicians and patients to adopt continuous cardiac monitoring technologies. Portable ECG monitors, Holter devices and wearable ECG patches enable long‑term tracking of heart rhythm outside clinical settings, capturing intermittent abnormalities that in‑clinic tests might also miss. These preventive monitoring trends support early diagnosis, reduce hospital readmissions and improve long‑term outcomes, driving broader adoption of diagnostic ECG devices across outpatient, community and remote care settings as part of comprehensive cardiovascular screening programs.
Another key driver for the diagnostic electrocardiography devices market is also rapid innovation in digital, wearable and AI‑enabled ECG technologies. Modern devices integrate wireless connectivity, cloud‑based data management and advanced signal processing algorithms that enhance accuracy and usability. Wearable ECG monitors and smart patches provide continuous cardiac data with minimal patient disruption, supporting remote patient monitoring and telehealth initiatives. Artificial intelligence (AI) and machine learning enhance arrhythmia detection and reduce false positives, improving diagnostic confidence for clinicians. These technological advancements are also expanding use cases, improving patient engagement and enabling more efficient, data‑driven cardiovascular care.
02

Restraint: High Costs of Advanced ECG Systems and Limited Reimbursement in Certain Regions

A key restraint for diagnostic electrocardiography devices is the high cost of advanced digital, multi‑lead and AI‑enabled ECG systems combined with limited reimbursement in some markets. Premium wearable and hospital‑grade ECG technologies may be out of reach for smaller clinics or providers in low‑income regions, reducing procurement demand. For example, lack of insurance coverage for continuous or remote ECG monitoring can deter adoption of ambulatory systems, slowing revenue growth for device manufacturers.
03

Opportunity: Growing adoption of home-based Diagnostic Electrocardiography Devices among ageing chronic cardiac patients in Western Europe and Integrating Diagnostic Electrocardiography Devices and AI-driven ECG software in tertiary hospitals across the United States

The ageing population of Western Europe and over stretched hospital capacity are causing a growing need for diagnostic electrocardiographs for home care use. Remote monitoring of cardiac patients is becoming more attractive to payers in order to cut readmissions of patients suffering from atrial fibrillation and heart failure. This has a particular benefit for compact wearable ECG devices and also for connected Holter monitoring devices, along with cardiology diagnostic equipment platforms. With strong growth coming from ambulatory and home healthcare applications, products that support the real time transmission of data will be popular, as will those enabling patients to manage their own care and that allow for monitoring of rhythms in advance.
US tertiary care hospitals are increasing their investments in diagnostic ECG devices equipped with ECG analysis software. The use of AI enabled ECG analysis, along with cloud based data connectivity and clinical decision support systems, is changing clinical work routines. This is leading to quicker diagnosis of difficult heart rhythms. The worldwide device revenue is forecast to climb from $5.97 billion in the year 2025 to $8.85 billion by 2030. Over the same period, it is predicted that the ECG software and services will grow from $3.24 billion to $4.43 billion. The company will see the fastest growth in software and services, notably stress ECG testing and AI subscription services.
04

Challenge: Data Privacy Concerns and Regulatory Hurdles Slowing Remote Cardiac Monitoring Adoption

Another significant challenge is data privacy concerns and stringent regulatory requirements for connected ECG and telehealth-based monitoring solutions. Regulations like GDPR and HIPAA require robust protection of patient cardiac data, and compliance increases development and operational costs. These barriers delay product rollouts and reduce clinician willingness to adopt cloud‑connected or AI‑integrated ECG devices, dampening market expansion in remote patient monitoring and digital health segments.

Supply Chain Landscape

1

ECG Components

Texas InstrumentsAnalog DevicesMurata Manufacturing
2

Diagnostic Electrocardiography-Devices

Koninklijke Philips N.V.GE HealthcareMedtronic
3

Medical Device-Distribution

Cardinal HealthMcKessonOwens & Minor
4

Cardiac Monitoring-End Users

HospitalsCardiology ClinicsAmbulatory Surgical Centers
Diagnostic Electrocardiography Devices - Supply Chain

Use Cases of Diagnostic Electrocardiography Devices in Routine Cardiac Check-ups & Intraoperative Monitoring

Routine Cardiac Check-ups : In routine cardiac check‑ups, resting electrocardiography devices are the most widely used tools to assess heart rhythm and electrical activity, providing clinicians with key diagnostics for arrhythmias, ischemia and other cardiac abnormalities. These devices are essential in outpatient clinics and primary care settings for baseline heart health assessments. Leading players like GE HealthCare, Philips Healthcare and Nihon Kohden offer robust ECG systems known for high signal fidelity, ease of use and comprehensive reporting features that enhance clinical workflows. Their established global presence and strong service networks make them preferred choices in routine diagnostics, supporting early detection and management of cardiovascular conditions.
Preventive Cardiology : In preventive cardiology, wearable and portable ECG monitors such as Holter monitors, event recorders and patch‑based systems are extensively used to continuously track cardiac activity over extended periods. These ambulatory devices help detect intermittent arrhythmias and silent cardiac events that may not appear during a short in‑clinic test. Companies such as AliveCor, BioTelemetry and GE HealthCare lead this segment by providing reliable, patient‑friendly solutions that integrate with digital health platforms for remote monitoring and data analytics. The ability to capture long‑term heart data supports risk stratification and early intervention, enhancing preventive care strategies.
Intraoperative Monitoring : For intraoperative monitoring, advanced multi‑lead ECG systems, integrated surgical monitors and real‑time telemetry solutions are critical in tracking heart function during surgical procedures, anesthesia administration and critical care. Devices from Masimo, Nihon Kohden and Philips Healthcare combine ECG with other vital parameters to provide continuous, accurate cardiac monitoring in operating rooms and intensive care units. Their strengths lie in high reliability, customizable alarms and seamless integration with hospital information systems. These systems enhance perioperative safety, enabling clinicians to respond rapidly to cardiac changes during complex interventions.

Recent Developments

The diagnostic electrocardiography devices market is advancing with AI‑enhanced ECG interpretation, digital health integration, and cloud‑based remote monitoring driving adoption across clinical and home care settings. Key suppliers are embedding machine learning algorithms and connectivity features into portable, multi‑lead, and wearable ECG systems to improve arrhythmia detection and support telecardiology. Rising demand for real‑time cardiac data analytics and seamless integration with electronic health records is shaping product innovation and expanding use in preventive cardiology and outpatient monitoring.

June 2025 : Nihon Kohden Corporation secured CE Mark approval for its new portable 12‑lead ECG system, expanding access to advanced cardiac diagnostics across European healthcare facilities and supporting ambulatory monitoring workflows.
May 2025 : Bittium announced a multi‑year agreement to supply ECG monitoring solutions to a major German hospital network, bolstering its presence in digital cardiac care infrastructure.
June 2024 : GE Healthcare launched a next‑generation AI‑powered electrocardiograph system aimed at improving diagnostic accuracy and workflow efficiency in hospital and clinical environments.

Impact of Industry Transitions on the Diagnostic Electrocardiography Devices Market

As a core segment of the Medical Device industry, the Diagnostic Electrocardiography Devices market develops in line with broader industry shifts. Over recent years, transitions such as Shift Towards Portable Devices and Integration of AI and Cloud-Based ECG Analysis have redefined priorities across the Medical Device sector, influencing how the Diagnostic Electrocardiography Devices market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Shift Towards Portable Devices

The trend of moving from conventional, equipment bound diagnostic technology to compact diagnostic equipment is driving new models of care and new revenue streams. Advances in portable ECG devices and wearable ECG monitors have made it possible for diagnostic functions to be used not only in hospitals and clinics but also in home healthcare and hospital at home settings. This has enabled remote monitoring of cardiac conditions and the early management of chronic diseases. This shift represents a fundamental change in direction, one which prioritises the needs of patients. It brings telecardiology work processes into alignment with patient centred care. It extends the availability of point of care testing to older people and those living in region's that are not only well served. The increasing use of portable ECGs and home based electrocardiography devices is likely to generate extra revenue of approximately $973 million by the year 2030. This rise in the adoption of mobile systems is crucial for both the suppliers and providers of diagnostic equipment, as it will set them apart and increase their profit margins.
02

Integration of AI and Cloud-Based ECG Analysis

The diagnostic electrocardiography devices market is witnessing a notable transition with the integration of artificial intelligence and cloud-based analytics. Modern ECG systems now leverage AI algorithms to detect arrhythmias, ischemic changes, and other cardiac abnormalities with higher accuracy and speed than traditional interpretation methods. Cloud connectivity allows secure storage, remote access, and real-time sharing of patient cardiac data with clinicians, supporting telemedicine and preventive cardiology initiatives. This transition impacts digital health platforms, remote monitoring services, and hospital IT infrastructure, enabling scalable cardiovascular care and improving workflow efficiency. Companies like AliveCor, Philips Healthcare, and GE HealthCare are leading this shift by offering AI-powered ECG solutions that enhance diagnostic confidence, facilitate early intervention, and reduce clinical burden, driving adoption across outpatient, inpatient, and home monitoring settings.