US market for wearable ECG testing estimated at $8B annually
Young Juhn, CEO of Wellysis “Speeding up product launch with our partner” 

Wellysis has announced that its patch-type electrocardiogram device, 'S-Patch,' has received approval from the U.S. Food and Drug Administration (FDA). The S-Patch is currently available in 14 countries.

On Sep. 5th, Wellysis announced that the S-Patch received approval through the FDA's '510(k) process.'

Weighing only 9g, the S-Patch features a small and lightweight cable-like patch design that minimizes noise while accurately collecting ECG waveforms. It can continuously measure for up to 100 hours without battery replacement, resulting in a high detection rate for arrhythmias. Additionally, it is equipped with waterproof functionality rated at 'IP55,' allowing comfortable wearing during daily activities. Inside the device, Samsung Semiconductor's specialized bio-processor efficiently collects and processes ECG signals.

Young Juhn, CEO of Wellysis, stated, "It is significant that the safety and efficacy of the S-Patch have been recognized in the United States, which is evaluated as the largest market in the wearable ECG testing market." He added, "Building on this approval, we will swiftly advance our plans for product launches with our partners in the United States."

The global wearable ECG testing market is estimated to be over 15 trillion won as of 2022, with the U.S. market accounting for approximately 55% of this figure. In the United States, there are over 11 million patients with arrhythmia-related diseases, and over 450,000 people are hospitalized annually due to atrial fibrillation. The medical expenses incurred by these patients amount to over 40 trillion won annually. Consequently, there is an increasing demand for patch-type ECG devices for early diagnosis and monitoring of arrhythmia diseases. Currently, such devices have captured a standard market share of 70% of all ECG tests.