Official BPM Vision Results BPM Vision is FDA-cleared and CE-marked, in compliance with medical device regulations. Its accuracy has been clinically validated.

• The Study: Conducted with 91 participants representative of the general population (men and women of all ages and blood pressure levels, with arm circumferences ranging from 22 to 52 cm or 9 to 20.5 inches), according to the ISO 81060–2:2018+A1:2020 standard.
• The Method: For each participant, 3 measurements from the BPM Vision were compared to 3 reference measurements (Korotkoff method) taken by two independent qualified observers.
• Accuracy Results:
  • Mean Error (Systolic): 0.2 mmHg
  • Mean Error (Diastolic): 0.76 mmHg

An additional clinical study is currently underway to validate the blood pressure measurement of the BPM Vision for the specific population of pregnant women. The objective is to obtain the clinical data required to officially prove the device's accuracy for this population.