Comment on "Feasibility of a New Cuffless Device for Ambulatory Blood Pressure Measurement in Patients With Hypertension: Mixed Methods Study".

Noud Van Helmond,Wim J Jongejan,Robert A Hirsh

doi:10.2196/15952

Abstract

Comment on "Feasibility of a New Cuffless Device for Ambulatory Blood Pressure Measurement in Patients With Hypertension: Mixed Methods Study".

Highlights

We read the article from Ogink and colleagues [1] describing the use of cuffless blood pressure (BP) measurement for home BP measurement
We are surprised that the authors refer to the prior study performed by Schoot et al [3] as promising in terms of European Society of Hypertension accuracy standards and by their repeated erroneous claim that the Checkme has Food and Drug Administration approval for measurements of systolic BP [1], after acknowledging the Checkme’s shortcomings related to accuracy and regulatory approval in a response to our letter [4]
It is important to note that the referenced CE (Conformitè Europëenne) certification constitutes conformity with electromagnetic safety standards but is not a certification for demonstrated accuracy and precision of systolic BP measurements

Summary

Introduction

We read the article from Ogink and colleagues [1] describing the use of cuffless blood pressure (BP) measurement for home BP measurement. We previously commented [2] on a prior study performed by the same group [3]. We highlighted problems with the Checkme’s accuracy and its marketing in the United States as a systolic BP monitor without the required Food and Drug Administration approval.

Results

Conclusion