To be (IIb), or not to be (IIb) - That is the current status of cuffless blood pressure monitoring device

초록

Cuffless blood pressure (BP) monitoring devices have attracted extraordinary scientific and commercial attention, yet their clinical status remains deeply contested. Major international guidelines from the American Heart Association/American College of Cardiology (2025), the European Society of Cardiology (2024), and the European Society of Hypertension (ESH, 2023) uniformly assign a Class III recommendation (not recommended for diagnostic use) to cuffless devices due to insufficient validation and calibration drift. However, the Korean Society of Hypertension has recently updated its guidelines to include cuffless BP monitors as a Class IIb recommendation for out-of-office BP measurement. This review explores the rationale behind this divergence, largely based on the acclumulating validation of a domestic ring-type cuffless device, CART BP (Sky Labs), currently the world's only nationally insured cuffless monitor. We analyze the historical landscape of international validation, detail the sequential fulfillment of ESH criteria, and delineate future research imperatives- emphasizing calibration practicality, transient BP changes, and cardiovascular outcome validation-to pave the way for universal clinical adoption.

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