The WAVE Project
AI-powered newborn brain assessment to support early detection of neurological injury at birth.
WHAT IS THE WAVE PROJECT
The Wave Project (previously called the Newborn Brain Screener) is a collaborative academic-industry project developing a novel platform to detect abnormal brain activity in infants at birth through an automated artificial intelligence assessment.
Funded by Enterprise Ireland through the Disruptive Technologies Innovation Fund (DTIF), University College Cork (UCC) through the INFANT Research Centre and CergenX Ltd, a UCC spinout company are working together to undertake this project and develop Wave.
Wave is an easy-to-use software medical device that interprets a short EEG recording and delivers binary results within minutes, indicating the presence or absence of abnormal EEG activity.
Designed to support clinician-led care for infants at risk of Neonatal Encephalopathy (NE), CergenX Wave complements clinical assessment and helps guide timely, individualised interventions. It can be used by non-specialist healthcare staff and is particularly valuable in neonatal units without onsite continuous EEG/aEEG or specialist EEG interpretation expertise.
WHY IT MATTERS
WHAT IS WAVE
CergenX’s Wave product:
- Is AI-enabled medical device software
- Analyses short newborn EEG recordings
- Detects abnormal brain activity
- Provides rapid binary feedback
- Supports clinician-led decision making
- Is designed for non-specialist neonatal settings
Wave is designed to complement clinical assessment in infants at risk of Neonatal Encephalopathy (NE).
THROUGH AI-POWERED NEWBORN BRAIN ASSESSMENT, THE WAVE PROJECT IS LAYING THE FOUNDATIONS FOR EARLIER DETECTION OF NEUROLOGICAL INJURY AT BIRTH TO BECOME A STANDARD OF CARE FOR BABIES WORLDWIDE
The ultimate goal is to establish a standard of care for all babies, consistent with the heel prick and audio screening tests which are mandated as a standard of care in healthcare systems.
CLINICAL VALIDATION
INFANT is the clinical lead for the project managing all clinical aspects, driving the design and execution of the data analysis studies and observational and regulated clinical trials, providing a pathway for access to clinical experts, parent advisory groups and education & training tools. INFANT is utilising this expertise and infrastructure to support all aspects of the project.
Key milestones:
- CE Marking achieved in 2026
- Multisite clinical investigational study started in autumn 2026
- Device validation 2026
- Feasibility clinical study completed in 2025
- FDA breakthrough designation status and acceptance into the FDA Technology Accelerator programme in 2025
- FDA De Novo submission planned for 2026
Research:
- Background EEG grading for the assessment of neonatal encephalopathy in full term neonates: https://doi.org/10.1016/j.semperi.2025.152163
NEWS AND UPDATES
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