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Comment on “Feasibility of a New Cuffless Device for Ambulatory Blood Pressure Measurement in Patients With Hypertension: Mixed Methods Study”
Author(s) -
Noud van Helmond,
Wim J Jongejan,
Robert A. Hirsh
Publication year - 2019
Publication title -
journal of medical internet research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.446
H-Index - 142
eISSN - 1439-4456
pISSN - 1438-8871
DOI - 10.2196/15952
Subject(s) - medicine , ambulatory , blood pressure , ambulatory blood pressure , intensive care medicine , cardiology
First, 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. 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.

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