Samsung Spinoff Wellysis Gets FDA OK for ECG Patch

Wellysis, a spinoff from Samsung SDS, has earned U.S. Food and Drug Administration (FDA) clearance for S-Patch Ex, its wearable electrocardiography (ECG) patch. S-Patch Ex gained CE mark clearance and is currently sold in 14 countries worldwide.
 
The S-Patch Ex ECG and heart rate recording device can be used both at home and in the clinic. It’s embedded with Samsung Electronics’ next-gen bio-processor, which the company said ensures the device captures accurate ECG waveforms. Wellysis expects it to officially launch in the U.S. in September.
 
The wearable patch weighs 9g and offers continuous test duration. It also integrates with mobile phones, tablets, and watches, and is compatible with any commercially available electrodes and batteries, Wellysis said.
 
S-Patch Ex is also reusable and has waterproof and dustproof features, boasting an IP55 rating.
 
“S-Patch Ex is designed with patience-centric for approach to ensure their comfort and ease of use in most daily activities. It also provides the most accurate information to the physicians. We are excited to introduce its outstanding features to the US market base with the FDA clearance in the U.S.,” Young Juhn, CEO and founder of Wellysis told the press.
 
S-Patch Ex is used mainly on patients with symptoms such as palpitations, the company said. Most recently, the device was also used in research with long COVID patients for ECG monitoring in Stanford University in the U.S. and Liverpool Hospital in Australia.