ArticleJMIR pediatrics and parenting2023
Iterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study.
Article in JMIR pediatrics and parenting, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
12 citing papers in PubMed, 20 citations in OpenAlex.
- Advancing neonatal jaundice screening with mHealth: a mixed-methods randomised controlled feasibility study in a resource-limited setting in Mexico.BMJ paediatrics open · 2026Trial
- Accuracy of non-invasive smartphone bilirubin measurements on neonates before and during phototherapy.European journal of pediatrics · 2026Article
- Evaluating the Picterus Jaundice Pro App for Neonatal Jaundice Screening by Parents: Prospective Mixed Methods Study.JMIR pediatrics and parenting · 2026Article
- Diagnostic accuracy of the Picterus jaundice Pro app for neonatal jaundice: a single-center study from Turkiye.Scientific reports · 2026Observational
- Machine reading and recovery of colors for hemoglobin-related bioassays and bioimaging.Science advances · 2025Article
- Smartphone-based screening of neonatal jaundice in three populations in low and middle-income countries: a cross-sectional study.BMJ paediatrics open · 2025Article
- Clinical superiority of artificial intelligence-enabled jaundice monitoring follow-up combined with end-tidal carbon monoxide measurement in neonatal jaundice management.American journal of translational research · 2025Article
- A Blueprint for Clinical-Driven Medical Device Development: The Feverkidstool Application to Identify Children With Serious Bacterial Infection.Mayo Clinic proceedings. Digital health · 2024Article
- Non-invasive detection of bilirubin concentrations during the first week of life in a low-resource setting along the Thailand-Myanmar border.BMJ paediatrics open · 2024Article
- Neonatal jaundice detection in low-resource Mexican settings: possibilities and barriers for innovation with mobile health.BMC health services research · 2024Article
- Identification and Quantification of Jaundice by Trans-Conjunctiva Optical Imaging Using a Human Brain-like Algorithm: A Cross-Sectional Study.Diagnostics (Basel, Switzerland) · 2023Article
- Validation of a Mobile Health Device for Neonatal Jaundice Screening: A Cross-Sectional Study in a Resource-Limited Setting in Mexico.Sage open pediatricsArticle
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMedical device development is an area facing multiple challenges, resulting in a high number of products not reaching the clinical setting. Neonatal hyperbilirubinemia, manifesting as neonatal jaundice (NNJ), is an important cause of newborn morbidity and mortality. It is important to identify infants with neonatal hyperbilirubinemia at an early stage, but currently there is a lack of tools that are both accurate and affordable.
objectiveThis study aimed to develop a novel system to assess the presence of NNJ. The device should provide accurate results, be approved as a medical device, be easy to use, and be produced at a price that is affordable even in low-resource settings.
methodsWe used an iterative approach to develop a smartphone-based system to detect the presence of NNJ. We performed technical development, followed by clinical and usability testing in parallel, after which we initiated the regulatory processes for certification. We updated the system in each iteration, and the final version underwent a clinical validation study on healthy term newborns aged 1 to 15 days before all documentation was submitted for conformity assessment to obtain Conformité Européenne (CE) certification. We developed a system that incorporates a smartphone app, a color calibration card, and a server.
resultsThree iterations of the smartphone-based system were developed; the final version was approved as a medical device after complying with Medical Device Regulation guidelines. A total of 201 infants were included in the validation study. Bilirubin values using the system highly correlated with total serum or plasma bilirubin levels (r=0.84). The system had a high sensitivity (94%) to detect severe jaundice, defined as total serum or plasma bilirubin >250 µmol/L, and maintained a high specificity (71%).
conclusionsOur smartphone-based system has a high potential as a tool for identifying NNJ. An iterative approach to product development, conducted by working on different tasks in parallel, resulted in a functional and successful product. By adhering to the requirements for regulatory approval from the beginning of the project, we were able to develop a market-ready mobile health solution.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.