Wellysis has secured FDA 510(k) clearance for S-Patch CardioAI, a software-as-a-medical-device product that analyzes ECG data and evaluates arrhythmias.
The Seoul company was spun out of Samsung SDS and already sells FDA-cleared S-Patch hardware for ECG acquisition. Adding CardioAI extends the offering beyond capturing a heartbeat to interpreting what the trace shows.
From patch to read
The clearance moves Wellysis into a crowded field of cardiac monitoring software, where wearable patches compete with smartwatches and implantable recorders to surface irregular rhythms.
Arrhythmia detection is one of the more established clinical uses of medical AI, and regulators have cleared a growing number of algorithms that read ECG strips.
The company announced the clearance on October 8. Pairing its own hardware with its own analysis software gives Wellysis a tighter loop than vendors that supply only one half of the chain.
Financial terms and commercial rollout details were not disclosed.
