Wellysis Receives US FDA Approval for S-Patch Ex

Wednesday, September 13, 2023

Wellysis has received clearance from the U.S. Food and Drug Administration (FDA) for U.S. market launch of its innovative wearable electrocardiography (ECG) patch, known as the S-Patch Ex.

This device is designed to record ECG and heart rate data, catering to both healthcare professionals and patients, with a strong emphasis on user comfort and ease of integration into daily activities. Additionally, the device is equipped with Samsung Electronics' cutting-edge Next-Generation bio-processor for precise capture of ECG waveforms. 

The S-Patch Ex boasts several remarkable features, including its exceptionally lightweight design at just 9 grams, an extended continuous testing capability, and seamless compatibility with mobile phones, tablets, and watches. It is also adaptable to commonly available electrodes and batteries, promoting reusability and cost-effectiveness.

The S-Patch Ex is primarily employed for patients exhibiting symptoms like palpitations. Furthermore, it has gained recent prominence in research focused on ECG monitoring among long COVID patients. This research initiative is being conducted at esteemed institutions such as Stanford University in the U.S. and Liverpool Hospital in Australia.


Source: prnewswire.com