High-sensitivity Electrocardiograph (hsECG) Testing Devices Market : Size, Share, Emerging Trends

The resting electrocardiogram (ECG) has been widely used as a cardiac monitoring system. However, the growing complexity in medical conditions has led to rising technology demands from consumers for enhanced mobility, ease of usage, interoperability, and streamlined workflow so that the data can easily be accessed with electronic medical records and enable physicians to accurately diagnose and treat the condition. Growing incidence of cardiovascular diseases has augmented demand for innovative devices for front-line testing of patients in its diagnosis and treatment. High sensitivity ECG testing devices hold significant promise for improvement in the detection of cardiac disease when compared to resting electrocardiogram (ECG) devices.

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Three major categories of cardiac disease include arrhythmia, structural heart disease, and coronary artery disease (CAD).The current resting electrocardiogram (ECG) devices, which function with traditional technology have several limitations in terms of detection of structural and CAD disease. Conventional resting ECG devices are unable to detect CAD in 50% of patients, leaving a large pool of patients undiagnosed. Current healthcare guidance does not recommend the use of resting ECG in asymptomatic patients. This has created a diagnostic gap for early detection of heart diseases. hsECG could play a significant role in early preventative treatment and diagnosis of many healthcare systems and thus reduce unnecessary healthcare expenditures. hsECG devices use an advanced form of signal processing called continuous wavelet transform, to transfer ECG signals into energy distribution during the cardiac cycle. Traditional ECG only examines analog waveforms of signals. The use of advanced form of signal processing increases the sensitivity of detection in the device for the presence of cardiac disease. A clinical trial conducted by HeartScience among 200 patients showed that the devices resulted in 87% specificity and 88% sensitivity in detection of cardiac dysfunction in the diastolic phase of the cardiac cycle. The advantages of hsECG over resting ECG, growing cardiovascular disease, and high prevalence of CAD worldwide is likely to drive the high-sensitivity electrocardiograph (hsECG) testing devices market.

The global high-sensitivity electrocardiograph (hsECG) testing devices market has been segmented based on applications, end-user, and region. In terms of applications, the market has been segmented into coronary artery disease (CAD), structural disease, arrhythmia, and others. Based on end-user, the market has been classified into hospitals, diagnostic centers, clinics, and ambulatory surgical centers. Hospitals segments is likely to dominate the market during the forecast period, owing to rising prevalence of cardiovascular disease and growing number of procedures of cardiac surgeries in hospitals.

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Geographically, the global high-sensitivity electrocardiograph (hsECG) testing devices market has been divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The only hsECG devices developed by HeartScience is under regulatory approval in Australia, Canada, Latin America, the Middle East, and Asia Pacific and the U.S. However, during the forecast period, North America is likely to expand at the highest CAGR in the global high-sensitivity electrocardiograph (hsECG) testing devices market. Strong product pipeline, presence of established players of the parent ECG device market in the U.S., and growing prevalence of cardiac disease in North America is anticipated to drive the market growth of high-sensitivity electrocardiograph (hsECG) testing devices in North America. Europe is anticipated to register the second highest growth in the high-sensitivity electrocardiograph (hsECG) testing devices market during the forecast period owing to early approval of high-sensitivity electrocardiograph (hsECG) testing devices in Europe and ease of availability of these devices for European cardiologists due to strong sales and distribution channels of manufacturers in Europe.

The key player operating in the global high-sensitivity electrocardiograph (hsECG) testing devices market is HeartScience. The product developed by HeartScience has received CE approval and will be soon available in the Europe market. The product is expected to be submitted for FDA approval in 2018. The company is seeking to receive regulatory approval in the Asia Pacific market in 2018.

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