Cardiovascular Monitoring And Diagnostic Devices And Equipment Global Market Report 2021: COVID 19 Impact and Recovery to 2030

Cardiovascular Monitoring And Diagnostic Devices And Equipment Global Market Report 2021: COVID 19 Impact and Recovery to 2030

  • April 2021 •
  • 175 pages •
  • Report ID: 6067853 •
  • Format: PDF
Major players in the cardiovascular monitoring and diagnostic devices and equipment market are Medtronic PLC, Boston Scientific Corporation, GE Healthcare, Johnson & Johnson and Philips Healthcare.

The global cardiovascular monitoring and diagnostic devices and equipment market is expected to grow from $2.46 billion in 2020 to $2.82 billion in 2021 at a compound annual growth rate (CAGR) of 14.6%. The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $3.72 billion in 2025 at a CAGR of 7.2%.

The cardiovascular monitoring and diagnostic devices and equipment market consists of sales of cardiovascular monitoring and diagnostic devices and equipment and related services.Cardiovascular monitoring and diagnostic devices and equipment are used for the diagnosis, monitoring, and treatment of cardiovascular diseases.

The key product types include Cardiopulmonary Stress Testing Systems, ECG Data Management Systems, ECG Monitoring Equipment, ECG Stress Testing Systems, Event Monitoring Systems, and Holter Monitoring Systems.

Companies in the cardiovascular monitoring and diagnostic devices and equipment market are developing implantable cardiac monitors (ICM) to monitor the heart rhythm.ICMs continuously monitor the electrocardiogram (ECG) of the patient to conduct a real-time examination of the heart rhythm, for up to 36 months.

ICMs are mostly used in the analysis of transitory symptoms which have an arrhythmic origin, such as unexplained palpitations. For example, in July 2020, Medtronic received U.S. Food and Drug Administration (FDA) clearance and European CE label approval for its Linq II insertable cardiac monitor (ICM) by remote programming, allows clinicians to optimize device settings without the requirement for patients to return to the hospital.

The cardiovascular monitoring and diagnostic devices and equipment market is being driven by an increasing number of people suffering from obesity and diabetes.Risk factors including high blood pressure and high cholesterol are associated with obesity and diabetes leads to cardiovascular diseases.

For instance, as per a study conducted by the American Heart Association (AMA), by 2030, 22.2 million of CVD is expected to grow. According to another study conducted by AMA in the U.S., 26 million people have been diagnosed with diabetes, and above 9 million further, have the condition but it hasn’t yet been diagnosed.

The US FDA has classified cardiovascular monitoring and diagnostic devices into the class II category, as they have a moderate to high risk associated with usage.Class II devices are bounded by device specific regulations which include performance standards, premarket data requirements, postmarket surveillance and labelling requirements associated with device usage.

For instance, the labelling should consist of contraindications, adverse reactions, precautions, warnings and other instructions before the device is released into the market.

The cardiovascular monitoring and diagnostic devices and equipment market is being restrained by the FDA’s regulatory control over these devices based on the risks associated with these equipment’s.Cardiovascular monitoring and diagnostic devices fall into the class II category as per the FDA, which includes devices with moderate to high risk associated with usage.

The Class II devices are specially controlled with performance standards which provide the manufacturers with performance specifications, postmarket surveillance which monitors the safety of the device after being released in the market and also other standards like patient registries and special labeling requirements.For instance, Angel medical systems’ implantable cardiac monitor was unanimously rejected by a panel of FDA experts due to unmet performance specifications.

In 2018, The FDA asked Angel to create a new clinical analysis plan after which the device was reapproved.