Paperdoi:10.1080/17434440.2026.2755200

Clinical testing of software and medical devices based on photoplethysmography (PPG) sensors: a scoping review

Venue listed2026Added Nov 2, 2026

  • MA
  • BC
  • B

Authors: de Melo Miranda AC, Berejuck MD (Federal University of Santa Catarina, Brazil)

Expert Review of Medical Devices, 2026-11-02 (online ahead of print), 1-13

TL;DR

Scoping review of 120 clinical studies of PPG-based devices and software published 2020-01-01 to 2025-10-27 (PubMed, Scopus, IEEE Xplore, Embase, WoS, Cochrane, ACM, CINAHL, LILACS, grey literature). It maps trial designs, populations, test settings, anatomical sites, safety reporting and methodological quality. The authors find broad clinical ambition but limited design rigour, small samples and poor reporting of population diversity, and expect international consortia to harmonise PPG validation frameworks within about five years.

  • Form factor: mixed (review)

Abstract

What clinical testing designs have been implemented for software and medical devices based on Photoplethysmography (PPG) sensors in healthcare settings?

Verbatim from OpenAlex (opens in a new tab) · Abstract via OpenAlex (publisher-deposited); © the authors/publisher

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Tasks & signals

Signals

Keywords

Scoping ReviewClinical ValidationValidation DesignPopulation DiversityRegulatoryDevice Validation

How it works

How Method works: Setup → Method → TargetSetup: Signals (PPG); Form factor (mixed (review)). Method: Method.SetupSignals: PPGSignalsPPGForm factor: mixed (review)Form factormixed (review)MethodMethod

Cite this paper

Cite this paper with the fields recorded here. Check it against the publisher before submitting.

de Melo Miranda, A. C., & Berejuck, M. D. (2026). Clinical testing of software and medical devices based on photoplethysmography (PPG) sensors: a scoping review. Expert Review of Medical Devices , 1-13. https://doi.org/10.1080/17434440.2026.2755200
de Melo Miranda, A C and M D Berejuck. 2026. "Clinical testing of software and medical devices based on photoplethysmography (PPG) sensors: a scoping review." Expert Review of Medical Devices , 1-13. https://doi.org/10.1080/17434440.2026.2755200.
de Melo Miranda, A. C. and Berejuck, M. D. (2026) 'Clinical testing of software and medical devices based on photoplethysmography (PPG) sensors: a scoping review', Expert Review of Medical Devices , 1-13. doi: 10.1080/17434440.2026.2755200.
de Melo Miranda, A C, and M D Berejuck "Clinical testing of software and medical devices based on photoplethysmography (PPG) sensors: a scoping review." Expert Review of Medical Devices , 1-13, 2026. https://doi.org/10.1080/17434440.2026.2755200.
A. C. de Melo Miranda and M. D. Berejuck, "Clinical testing of software and medical devices based on photoplethysmography (PPG) sensors: a scoping review," Expert Review of Medical Devices , 1-13, 2026, doi: 10.1080/17434440.2026.2755200.
@article{miranda2026clinical,
  title         = {{Clinical testing of software and medical devices based on photoplethysmography (PPG) sensors: a scoping review}},
  author        = {de Melo Miranda, A. C. and Berejuck, M. D.},
  year          = {2026},
  journal       = {Expert Review of Medical Devices , 1-13},
  doi           = {10.1080/17434440.2026.2755200}
}

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