Clinical Evidence

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

Download our White Paper

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
  • The results suggest that Picterus JP can:
    • Reduce unnecessary blood draws
    • Support timely referral of at‑risk newborns

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 etal. (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

Manuscripts have been submitted for peer review and are expected to be published in 2026.

Additionally, further clinical studies are currently ongoing.

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

The first CE approved 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

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 approval

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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Access our neonatal jaundice and Picterus Jaundice Pro e-learning course

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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