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.