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

ABSTRACT:

Background

Medical 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.

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.

Methods

We used an iterative approach to develop a smartphone-based system to de

SUBMITTER: Aune A 

PROVIDER: S-EPMC10015352 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature