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Samsung’s Galaxy Watch Wins MFDS Nod to Screen for Heart Failure Risk

Global availability hinges on regulatory clearance beyond South Korea.

Overview

  • Samsung announced an AI feature that analyzes a Galaxy Watch single‑lead ECG to detect Left Ventricular Systolic Dysfunction, a key driver of heart failure.
  • The company says the technology completed trials and secured approval from South Korea’s Ministry of Food and Drug Safety.
  • The algorithms were built with Medical AI and are based on its 12‑lead ECG models used in more than 100 Korean hospitals serving roughly 120,000 patients each month.
  • Samsung says release in other regions will follow additional approvals and characterizes the capability as a first for smartwatches.
  • Separately, Samsung is testing an ear‑worn EEG prototype for drowsiness and content‑response monitoring, with potential nonclinical applications still exploratory.