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BPM Connect has received FDA and CE clearance for medical devices.

The BPM Connect performance to measure blood pressure was validated in a clinical trial of 87 participants representative of the intended population: adults from the general population with an arm range of 22-42 cm (9 to 17 inches) and all grades of blood pressure.

For each participant, 3 measurements were taken and compared with 3 measurements acquired for reference (by Korotkoff method) determined by two trained independent observers. The mean error is -0.27 mmHg for systolic blood pressure and -0.16 mmHg for diastolic blood pressure, and the standard deviation of the error is 7.46 mmHg and 5.85 mmHg respectively.

These results are well within the margin of acceptance defined by the internationally recognized evaluation standard of blood pressure monitors ANSI/AAMI/ISO 81060-2:2013, EN ISO 81060-2:2014, developed by the European Society of Hypertension and British Hypertension Society.

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