Clinical validation of the MED-58 upper-arm automated oscillometric blood pressure monitor with fan-shaped and rigid cuffs for home and clinical use in adolescents and adults, according to International Organization for Standardization 81060-2:2018 (

This study validated the accuracy and safety of the MED-58 upper-arm automated oscillometric blood pressure monitor - intended for home and clinical use - with fan-shaped and rigid cuffs, per International Organization for Standardization (ISO) 81060-2:2018 (Amd.1:2020; Amd.2:2024). In this prospective, single-center validation study, participants aged ≥12 years were allocated to a fan-shaped cuff group (n = 85) or a rigid cuff group (n = 85). Per group, oscillometric readings with the MED-58 were compared with reference auscultatory measurements using the same-arm sequential method in ISO 81060-2. Blood pressure accuracy was assessed against ISO criterion 1 and 2. Secondary endpoints included pulse rate accuracy (±5% margin vs. manual palpation), device usability/performance, and safety. Both cuff configurations met ISO accuracy requirements. In the fan-shaped group, mean (±SD) device-reference differences were 1.1 ± 5.4 mmHg (SBP) and 0.3 ± 4.0 mmHg (DBP); SDs of per-participant mean differences were 4.4 mmHg (SBP) and 3.3 mmHg (DBP). In the rigid group, mean differences were 0.8 ± 5.2 mmHg (SBP) and 0.6 ± 4.5 mmHg (DBP); SDs of per-participant mean differences were 4.2 mmHg (SBP) and 3.8 mmHg (DBP). Mean pulse-rate differences were 1.65 bpm (fan-shaped) and 1.76 bpm (rigid), both within the prespecified ±5% equivalence margin. No adverse events were reported. The MED-58 demonstrated accuracy consistent with ISO 81060-2:2018 (Amd.1:2020; Amd.2:2024) with either cuff, with good usability and short-term safety.