BPM Connect is FDA-cleared and CE-marked, in compliance with medical device regulations. Its accuracy has been clinically validated in two types of populations:

General Population [https://pubmed.ncbi.nlm.nih.gov/35386428/]

• The Study: Conducted with 85 adult participants representative of the general population (men and women of all ages and blood pressure levels, with arm circumferences ranging from 22 to 42 cm), according to the ISO 81060–2:2018 standard.
• The Method: For each participant, 3 measurements from the BPM Connect were compared to 3 reference measurements (Korotkoff method) taken by two independent qualified observers.
• Accuracy Results:
  • Mean Error (Systolic): 0.6 mmHg
  • Mean Error (Diastolic): 2.1 mmHg

Specific Population – Pregnant Women [https://pmc.ncbi.nlm.nih.gov/articles/PMC8967988/]

• The Study: Conducted with 45 adult women during their second or third trimester of pregnancy, divided into three groups of 15 participants based on their diagnosis: pre-eclampsia, gestational hypertension, or normal blood pressure.
• The Method: For each participant, 3 measurements from the BPM Connect were compared to 3 reference measurements (Korotkoff method) taken by two independent qualified observers.
• Accuracy Results:
  • Mean Error (Systolic): -0.5 mmHg
  • Mean Error (Diastolic): -0.8 mmHg