Cardiovascular Monitoring and Diagnostic Devices Market to Witness Robust Growth in North America
The cardiovascular monitoring and diagnostic devices market
is witnessing strong growth in North America, owing to the increasing
prevalence of cardiovascular diseases in the region. According to the Centers
for Disease Control and Prevention (CDC), one person dies every 36 seconds from
cardiovascular disease in the United States. Around 655,000 people (one in
every four) in the U.S. die from heart disease each year. Cardiovascular
disease is the leading cause of death for men, women, and people of most racial
and ethnic groups in the United States. Thus, there is an increasing demand for
cardiovascular monitoring and diagnostic devices in North America, especially
in the United States.
In February 2021, RhythMedix launched its next-generation
RhythmStar wearable device with built-in 4G cellular connectivity. The
technology enables rapid ECG analysis and reporting of cardiac abnormalities by
RhythMedix's team of U.S.-based certified technicians, who alert physicians if
an arrhythmia of concern is detected. Cardiovascular monitoring and diagnostic
devices, such as event monitoring devices, ECG stress testing, Holter
monitoring device, and ECG monitoring device, are used to monitor heart patients
who are suffering from different cardiovascular diseases. Increasing approvals
and launches of new devices is also driving the cardiovascular monitoring and diagnostic
devices market.
For example, in November 2019, Shimmer received CE
certification for its five-wire, four-lead Holter monitor electrocardiogram ECG.
It is now a CE certified, Class II medical device under the Medical Device
Directive (93/42/EEC). Moreover, ECGmd is now recognized as a medical device in
Europe, capable of providing medical-grade ECG output from Shimmer’s wearable
sensor. This in turn is expected to accelerate the growth of the cardiovascular
monitoring and diagnostic devices market in Europe. Moreover, increasing
geriatric population is also expected to aid in growth of the market. For
instance, according to the U.S. Census Bureau, the United States will experience
considerable growth in its older population, between 2012 and 2050.
In 2050, the population aged 65 and over is expected to
reach 83.7 million, almost double its estimated population of 43.1 million in
2012. However, the U.S. Food and Drug Administration (FDA) has implemented stringent
rules and regulations for in-vitro testing of ECG Devices, which includes
electrical safety, software testing, environmental testing, and electromagnetic
compatibility of the devices. Moreover, the time needed for approval 510(K) has
also been increased due to the complexity and volume of medical devices
marketing submissions, from 90 days to 140 days. The aforementioned factors are
expected to restrain the growth of the cardiovascular monitoring and diagnostic
devices market.
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