DiaTecne PulsePen (V1)
The technology used in the DiaTecne PulsePen (V1), to measure blood pressure, has been assessed, in a general population, according to a non-standard protocol.
|Medaval||None||When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.|
Salvi P, Lio G, Labat C, Ricci E, Pannier B, Benetos A. Validation of a new non-invasive portable tonometer for determining arterial pressure wave and pulse wave velocity: the PulsePen device. J Hypertens. 2004 Dec;22(12):2285-2293. doi: 10.1097/00004872-200412000-00010. PMID: 15614022.
Ad Hoc protocol General population
While this paper concludes that "the PulsePen enables an easy and reliable evaluation of central arterial pressure and stiffness", a standard protocol was not used and only percentage differences are provided, with no defined pass/fail criteria.
Joly L, Perret-Guillaume C, Kearney-Schwartz A, Salvi P, Mandry D, Marie PY, Karcher G, Rossignol P, Zannad F, Benetos A. Pulse wave velocity assessment by external noninvasive devices and phase-contrast magnetic resonance imaging in the obese. Hypertension. 2009 Aug;54(2):421-426. Epub: 2009 Jun 8. doi: 10.1161/HYPERTENSIONAHA.109.133645. PMID: 19506096.
This study concludes that, for body mass index values ≤ 35 kg/m², PWV measured externally with a PulsePen reflect values obtained directly in the thoracic aorta, through MRI, validly.