Seoul, South Korea–based Wellysis announced today that it has secured FDA clearance for its S-Patch Ex. The device already has a CE Mark, with Wellysis marketing the S-Patch Ex in 14 countries. Its markets include the U.K., Spain, Italy, Greece, Poland, Australia, Thailand, India, and Korea.
Wellysis plans a U.S. launch this month by establishing partnerships with service and platform providers.
The company sees uses for the ECG and heart rate recording device in both home and clinical settings. Samsung Electronics’ next-generation bio-processor, embedded in the S-Patch Ex, ensures accurate ECG waveforms, according to Wellysis.
“We are excited to introduce its outstanding features to the U.S. market base with the FDA clearance in the U.S.,” Wellysis founder and CEO Young Juhn said in a news release.
Wellysis enters a crowded field in the United States. Companies including iRhythm, Baxter’s BardyDx, AliveCor and more are marketing lightweight ECG sensors meant to move cardiology beyond the bulky Holter monitors that doctors have sent patients home with to monitor for AFib and other conditions.
When it comes to the S-Patch Ex, Wellysis officials have seen health providers use it predominantly on patients with symptoms such as palpitations. Research institutions such as Stanford University in the U.S. and Liverpool Hospital in Australia have also recently used the device to gather ECG data from long COVID patients.
Juhn and others at Wellysis see the S-Patch Ex as competitive because of its light weight of 9 g. Other features include:
- Continuous test duration;
- Integrates with mobile phones, tablets, and watches;
- Compatible with commercially available electrodes and batteries;
- Reusable;
- Equipped with waterproof and dustproof features;
- Boasting an IP55 rating, ensuring durability in various conditions.
Juhn touted what he said was the S-Patch Ex’s patient-centric design, meant to ensure comfort and ease of use. “It also provides the most accurate information to the physicians.”
