Iterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study

Anders Aune
Gunnar Vartdal
Gabriela Jimenez Diaz
Lobke Marijn Gierman
Håkon Bergseng
Elisabeth Darj

Objective: This 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.

Results: Three 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%).

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