Wellysis’ Wearable Electrocardiology Patch Receives FDA Approval
S-Patch Ex designed to record heart rate both at home and in a clinical setting.
Wellysis, an offshoot of Samsung SDS, announced that it has received FDA clearance to promote its wearable electrocardiography (ECG) patch, S-Patch Ex, in the US. Currently, the patch is being distributed to 14 countries including UK, Spain, Italy, Greece, Poland, Australia, Thailand, India, and Korea. Expected to be launched this month, the product is embedded with Samsung Electronics’ bio-processor which ensures the device captures accurate ECG waveforms.
"S-Patch Ex is designed with patience-centric for approach to ensure their comfort and ease of use in most daily activities,” said Young Juhn, CEO, founder, Wellysis. “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 US.”
Reference: S-Patch Ex, Wearable ECG Patch, Cleared by US FDA. PR Newswire. September 13, 2023. Accessed September 13, 2023. https://www.prnewswire.com/news-releases/s-patch-ex-wearable-ecg-patch-cleared-by-us-fda-301922877.html
