Patches allow remote electrocardiograms

Two new patches for remotely performing electrocardiogram (ECG) tests, from different manufacturers, have been authorized by the Food and Drug Administration (FDA), the US food and drug control agency, to be marketed in the country.

One of them is the S-Patch Ex, which was developed by Wellysis, a spin-off from Samsung SDS, and has already received CE certification from the European Union (related to safety, health and environmental protection requirements) in May 2021. It is currently being exported to 14 countries around the world.

The S-Patch Ex is a device that records ECG and heart rate data for use by healthcare professionals and patients at home or in clinical settings. The product integrates Samsung Electronics’ bioprocessor that captures ECG waveforms. The product is expected to be officially launched on the North American market through partnerships with service providers and platforms.

The S-Patch Ex weighs just 9 grams, the lightest device in its category according to the manufacturer, and can be used with mobile phones, tablets and smartwatches, as well as being compatible with any electrodes and batteries available on the market. It is reusable and waterproof and dustproof, with an IP55 rating, which guarantees durability in various conditions.

The indication for use of S-Patch Ex is predominantly in patients with symptoms such as palpitations and shortness of breath. The S-Patch application automatically terminates the test after the prescribed duration and uploads the data to the cloud, where it will be available for diagnosis by the doctor.

More recently, the device has also been used in research with long-term COVID patients for monitoring by institutions such as Stanford University in the United States and Liverpool Hospital in Australia.

Real time monitoring

The second patch to receive FDA authorisation is the SmartCardia 7L, which monitors ECG results in real time. It is also waterproof and can be worn continuously for up to 14 days. According to the manufacturer, one of the main limitations of the cardiac patches currently available on the market is the inability to detect arrhythmia accurately. The SmartCardia 7L patch, on the other hand, features excellent P and QRS waves, unprecedented signal quality, and allows for the accurate detection of arrhythmias thanks to its seven ECG leads. The 7L platform can also provide visual and audible alarms and notifications to doctors.

“The entire ECG data, not just the events, is transmitted in real time, and automated analysis is carried out on the signals. The complete analysis makes it possible to detect arrhythmia precisely. In addition, easy navigation through the cloud platform gives the doctor the resources to quickly view and analyse ECG data at any time,” explains Francisco Rincon, SmartCardia’s technical director.

The company is expanding its presence around the world. The company was recognised by Frost & Sullivan with the 2022 Global New Product Innovation Award in cardiac monitoring.

An article in The Lancet Digital Health highlights that incorporating data from wearable devices into clinical decision-making in cases of cardiovascular disease could be interesting, as patients could already provide information about their health conditions at the first consultation, and this has the potential to revolutionise the traditional doctor-patient interaction. Medical consultations could no longer be based solely on patients’ recollections, but on a standardised series of objective parameters collected over a period of days or months. In addition, the combination of wearable devices with telemedicine could generate significant changes in community care, as well as a reduction in both hospital admissions and health-related costs.

However, the article warns of the risks of the ubiquitous use of wearable devices in clinical decision-making without validation. There are still not enough studies demonstrating improvements in medical outcomes, listing risks and benefits for patients and health systems.

The global market for wearable cardiac monitoring devices is expected to show a compound annual growth rate of 12.5 percent between 2022 and 2031, totaling $5.8 billion by the end of the forecast period, according to a report by Transparency Market Research.

The adoption of this type of device that facilitates remote monitoring is being driven by growing awareness of the importance of a healthy lifestyle and preventive health care. In addition, the integration of heart rate monitoring features into smartwatches is popularizing the use of this tool among various population groups.