Clinical Evidence

At Picterus, we are committed to improving neonatal jaundice screening through rigorous clinical research, supported by peer–reviewed evidence and realworld validation across diverse care pathways, including both clinical and home settings. 

White Papers

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Want to learn more about the science and validation behind Picterus Jaundice Pro? Download our latest white paper to explore the clinical background, methodology, and global relevance of our screening solution.

Key findings:

  • Picterus JP showed a high correlation with total serum bilirubin (TSB) levels.
  • The device demonstrated high sensitivity and specificity in identifying newborns at risk of developing severe neonatal jaundice.
  • Picterus JP showed high decision accuracy for identifying which infants required:
    • Further diagnostic follow‑up
    • Confirmation with a blood test
    • According to recommendations for post-discharge follow-up in “Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation” from the American Academy of Pediatrics (2022)
  • The results suggest that Picterus JP can:

    • Reduce unnecessary blood draws
    • Support timely referral of at‑risk newborns

Picterus® Jaundice Pro as a screening tool for neonatal jaundice

By CW Yoxall. B.Med.Sci., B.M., B.S., M.R.C.P, F.R.C.P.C.H., M.D. Consultant Neonatologist.

The aim of this investigation has been to evaluate the precision of the Picterus JP system in measuring jaundice in the newborn and to assess its potential role as a screening device. The evaluation has been performed on data from 790 newborns across 8 international studies, representing a broad range of clinical settings, populations, and skin tones.

Key findings:

  • Picterus® Jaundice Pro showed a strong correlation with laboratory bilirubin measurements (TSB), supporting its potential role as a non-invasive screening tool for neonatal jaundice.
  • When evaluated against UK neonatal jaundice treatment guidelines (NICE), the device identified all infants requiring phototherapy within this study cohort.
  • Findings suggest that the device may help
    • identify which newborns require further evaluation with a blood test
    • reduce unnecessary blood sampling: Modelled estimates suggested a potential reduction of approximately 20-35% in TSB measurements.
  • Screening performance appeared consistent across a diverse range of skin tones, with skin pigmentation showing no clinically meaningful impact on results.
  • As with transcutaneous bilirubinometers (TcB), Picterus JP is intended as a screening tool rather than a replacement for laboratory bilirubin testing, and further validation in an independent study population is recommended.

Scientific Publications

Picterus Jaundice Pro has undergone multiple software generations since its initial clinical validation. Each generation represents a distinct version of the algorithm and user interface, reflecting ongoing development and improvements informed by clinical research and realworld use. When reviewing the clinical evidence, it is therefore important to consider the software version used in each study, as well as the intended use context at the time of evaluation. 

Our journey of initial development, validation, and certification is described in the paper by Aune et al. (2023). 

2025 - Present

Next‑generation model & broader inclusivity
-
best performance to date

2023 - 2024

Expanded clinical use and usability improvements

2021 - 2022

First CE‑marked medical device

2017 - 2020

Clinical validation and patented technology

2012 - 2016

Concept & feasibility research

Current generation
V3, from 2025 onward

Over time, the software evolved toward more data driven approaches, including the use of machine learning methods, enabling performance to be refined based on accumulated clinical experience. 

Related publications
2026

Evaluating the Picterus Jaundice Pro App for Neonatal Jaundice Screening by Parents: Prospective Mixed Methods Study

Subsequent generations
First CE approved version.
V2, from 2021 onward

The first CE marked and commercially available generations of the software introduced refinements to image analysis, calibration, and user experience, informed by additional clinical data, expanded use contexts, and feedback from healthcare professionals. This also included an updated version of the Picterus Calibration Card, with added colour swatches to open for a wider variety in colour interpretation.   

Related publications
2025

Advancing neonatal jaundice screening with mHealth: a mixed-methods randomised controlled feasibility study in a resource-limited setting in Mexico.

2025

Validation of a Mobile Health Device for Neonatal Jaundice Screening: A Cross-Sectional Study in a Resource-Limited Setting in Mexico.

2025

Smartphone-based screening of neonatal jaundice in three populations in low and middle-income countries: a cross-sectional study.

2024

Neonatal jaundice detection in low-resource Mexican settings: possibilities and barriers for innovation with mobile health.

2023

Healthcare workers’ perceptions about the use of mobile health technologies in public health facilities in Lagos, Nigeria.

Earlier generations
Proof of concept,
pre-CE mark

The earliest version of Picterus Jaundice Pro relied on predefined analytical models informed by simulated skin characteristics and reference bilirubin values. The first generation of the app supported foundational feasibility and validation studies and established the clinical potential of smartphone based bilirubin screening. Details are described in the related publications.

Related publications
2020

Bilirubin estimates from smartphone images of newborn infants’ skin correlated highly to serum bilirubin levels.

2023

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

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This Course will equip you with the essential knowledge and practical skills to confidently assess and manage neonatal jaundice, using tools like Picterus® Jaundice Pro for accurate screening. You’ll also explore clinical guidelines and best practices to ensure that your decisions align with clinical recommendations.

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