FDA cleared S-Patch CardioAI, Wellysis' arrhythmia analysis software, on September 25 under K254255 and product code DPS. The company announced the clearance on October 8.
Wellysis already held clearance for the S-Patch hardware that records the ECG. CardioAI is the Class II software that reads it, and the company is selling it as a component other people build on: remote patient monitoring providers, independent diagnostic testing facilities and CROs, priced by subscription or by test.
Wellysis spun out of Samsung SDS in 2019 and opened a US subsidiary in Houston in 2023, at the Texas Medical Center after a stint in the JLABS program. CEO Young Juhn said US revenue more than quadrupled from 2024 to 2025.
Clearing acquisition and analysis separately is the useful part here. An IDTF that already owns patches can buy the algorithm without touching its hardware, and Wellysis can sell either half. The release carries no sensitivity or specificity figures, so any comparison against the incumbent algorithms waits for the decision summary.