Electrocardiograms (ECGs or EKGs) are diagnostic tests carried out to detect abnormalities of the heart by measuring its electrical activity. Typically, ECGs require 12 to 15 sensors attached to the body in different locations for five to ten minutes, which measure the heart’s electrical activity.

This procedure is traditionally carried out in a hospital, a physician’s office, or in a laboratory setting. However, companies such as Apple, AliveCor, Qardio and Withings are making strides to push cardiac monitoring into the hands of the patient, rather than the clinic, through use of personal, portable ECG monitors.

In 2012, AliveCor received FDA 510(k) clearance for its mobile health monitor, a small, portable medical device and associated smartphone app with the ability to record, display, store, transfer, and evaluate single-channel ECG readings. Since then, AliveCor has progressively updated its device, securing further FDA clearances along the way to add more and more diagnostic functionality. Today, AliveCor’s Kardia device is FDA-approved to detect atrial fibrillation (Afib), brachycardia and tachycardia. The device is being sold across North America and Europe.

Smart watches lead the way

More recently, Apple has entered the portable, personal ECG market with its Apple Watch Series 4. ECG functionality for the watch received FDA 510(k) clearance in 2018. The advantage of Apple’s device is its integration with other built-in health features of the smartwatch, such as the activity tracker, fall detector, menstrual tracker, and more.

However, since it is newer to market, the Apple Watch ECG function is currently only commercially available in the US and some countries in Europe, with further global releases planned in the future.

Wearable devices, in general, are gaining huge traction as healthcare devices, and smartwatches are among the biggest players in this market. GlobalData estimates that 13.8% of the US population aged 12–100 owned a wrist-worn wearable in 2018, which is predicted to grow at a staggering Compound Annual Growth Rate (CAGR) of 12% between 2018 and 2024.

Room for improvements

Factors driving this market include America’s ageing population, who are invested in preventative healthcare, an increased focus on patient-centred care and improving the technology. Barriers to this market include the inaccuracy of data and analysis, concerns over data privacy and slow regulation timelines. Apple dominates this market, while smaller companies that specialize in personal medical devices (such as AliveCor, Withings and Qardio) are also major players.

Given the strong entry of multiple personal ECG devices into the market in recent years, GlobalData expects a shift in cardiac monitoring guidelines to occur in the forecast period. Within the near future, personal ECGs will likely be recommended for general cardiac monitoring and maintenance. However, personal ECGs will probably not completely replace regular doctor visits (especially for important diagnoses) until technology improves and clinical trials provide more evidence for data accuracy.