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Oct 08, 2026, 10:00 ET Wellysis Secures FDA 510(k) Clearance for AI-Powered ECG Analysis Software, S-Patch CardioAI
(SaMD) designed to analyze ECG data and evaluate arrhythmias. Wellysis already provides FDA-cleared S-Patch hardware for ECG acquisition, and the addition of CardioAI brings FDA-cleared AI analysis to the S-Patch solution, extending Wellysis' capabilities from ECG acquisition through AI-powered analysis.Under
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