Electrocardiogram (ECG) Devices Market Current Situation and Growth Analysis to 2026 | Leading Players Cardiac Insight Inc., Koninklijke Philips N.V., General Electric Company, CardioNet Inc., Mindray Medical International Limited, Spacelabs Healthcare

Electrocardiograph machines are used to measure the electrical activity of a patient’s heart. The electrical activity of the heart is recorded with the help of 12-lead ECGs and 10 electrodes, placed on patient’s limbs and surface of the chest. Furthermore, ECG used to monitor patient’s emergency situation to obtain quick results of heart’s size, position of heart chambers, the rate of the heart, rhythm, and any damage to heart muscles and effect of cardiac drugs. The 12-lead electrocardiogram (ECG) is the most common and widely used in the assessment of cardiovascular disease including cardiac rhythm, detection of myocardial ischemia and infarction, conduction system abnormalities, preexcitation, long QT syndromes, atrial abnormalities, ventricular hypertrophy, pericarditis, and other conditions.

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Approval and launch of novel electrocardiogram (ECG) devices and high prevalence of cardiovascular diseases expected to drive global electrocardiogram (ECG) devices market growth

Launch and approval of novel electrocardiogram (ECG) devices in market is expected to drive global electrocardiogram (ECG) devices market growth over the forecast period. For instance, in January 2019, Alphabet Inc.'s health division, Verily received approval from the U.S. Food and Drug Administration (FDA) for Verily’s Study Watch, a wearable medical device that conducts electrocardiograms (ECGs), which measures electrical activity of the heart and can be used to diagnose a number of heart conditions.

According to the same source, coronary heart disease was the leading cause of death (43.8%) in the U.S., followed by stroke (16.8%), heart failure (9.0%), high blood pressure (9.4%), diseases of the arteries (3.1%), and other cardiovascular diseases (17.9%).

The global electrocardiogram (ECG) devices market size was valued at US$ 4.2 Bn in 2018, and is expected to witness a CAGR of 5.8% during the forecast period (2018–2026).

Asia Pacific is expected to hold dominant position in the market, owing to high prevalence of typhoid fever in the region

North America electrocardiogram (ECG) devices market is expected to hold dominant position in global electrocardiogram (ECG) devices market, owing to high awareness regarding health and frequent investments by key players in market to launch novel electrocardiogram (ECG) devices in the region. For instance, in 2017, the U.S.-based Cardiac Insight Inc. received the U.S. Food and Drug Administration approval for its novel wearable ECG sensor namely Cardeo Solo. The company has raised around US$ 4.5 million to develop and commercialize its novel wearable.

Furthermore, Asia Pacific electrocardiogram (ECG) devices market is expected to be a potential market for key players, owing to increasing ageing population and rising prevalence of cardiovascular disease in key regions of Asia Pacific including China and India. For instance, according to the data published by the World Health Organization (WHO), in China cardiovascular disease is estimated to increase by 50% between 2010 and 2030 based on population aging and growth.

Regulatory Scenario

The Food & Drug Administration (FDA) in the U.S., European Medicines Agency (EMA) in Europe, Therapeutic Goods Administration (TGA) in Australia, and other similar authorities in the respective regions oversee the regulations associated with medical devices. The U.S. Food & Drug Administration (FDA) oversees all the activities associated with food and medical products in the North America region. Under medical devices, all types of medical devices for all types of conditions are considered.

Medical devices are classified into three categories such as Class 1, Class 2, and Class 3 medical devices. This classification is risk-based, where risk posed by the device to the patient represents category of the medical device. For instance, class 1 includes devices with lowest risk, whereas class 3 includes devices with greatest risk. Electrocardiogram (ECG) devices come under class II of medical devices.

Key players operating in the global electrocardiogram (ECG) devices market include Cardiac Insight Inc., Koninklijke Philips N.V., General Electric Company, CardioNet Inc., Mindray Medical International Limited, Spacelabs Healthcare (a subsidiary of OSI Systems Inc.), Schiller AG, CompuMed Inc., Nihon Cohden Corporation, and Welch Allyn, Inc.

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