Competition in the wearable ECG space continues to heat up, with Samsung spinoff Wellysis as the latest U.S. market entrant.
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.