Regulatory approval clears path for European rollout of Irish-made Wave from Cork business CergenX, designed to provide rapid insights into newborn brain injury.
Irish medtech firm CergenX has achieved CE Mark certification under EU MDR 2017/745 for its AI-powered newborn brain assessment technology, Wave, marking a significant regulatory milestone as the company prepares for commercial expansion across Europe.
The Cork-based company said the certification enables it to bring Wave to the European market, supporting clinicians with rapid, objective assessments of newborn brain activity and abnormalities associated with brain injury.
“It takes us another important step closer to our goal of making newborn brain assessment more widely available”
More than 1 million newborns worldwide are affected by brain injury each year. While electroencephalography (EEG) is regarded as the gold standard for assessing newborn brain function, access remains limited, with more than 80% of hospitals worldwide unable to provide EEG services or specialist interpretation.
Data-driven insights
Developed to address this challenge, Wave uses four electrodes, an EEG amplifier and a tablet interface to analyse 10 minutes of newborn brain activity. The data is assessed using CergenX’s proprietary artificial intelligence technology, delivering a result in as little as 30 seconds.
The company says the technology is designed to provide expert-level EEG assessment without requiring specialist EEG interpretation, helping clinicians gain objective, data-driven insights into neonatal brain function and EEG abnormalities linked to known markers of brain injury.
Jason Mowles, co-founder and CEO of CergenX, described the certification as a major achievement for the business.
“Achieving CE Mark certification is a hugely significant milestone for CergenX and the result of several years of work by our team, collaborators and clinical partners.
“It takes us another important step closer to our goal of making newborn brain assessment more widely available. With CE Mark certification now achieved, our focus turns to bringing Wave to the European market and putting this technology into the hands of clinicians.”
Early diagnosis remains a critical factor in the treatment of newborn brain injury. Therapeutic hypothermia, one of the most effective interventions for certain forms of brain injury in newborns, must begin within six hours of birth to achieve the best outcomes. Earlier assessment can also help determine whether infants require specialist intervention or transfer to higher-acuity care centres.
Wave has been developed as a clinical decision-support tool, providing clinicians with objective assessments to support clinical decision-making.
Professor Geraldine Boylan, co-founder and chief scientific officer of CergenX, said the company was established to address longstanding gaps in neonatal brain assessment.
“We founded CergenX to address a very clear unmet clinical need. EEG provides vital information about newborn brain function, yet access to EEG and the expertise required to interpret it remains limited in many hospitals.
“For babies at risk of brain injury, timely assessment matters. Wave has been developed to bring rapid, objective EEG assessment to the point of care, giving clinicians clear information to support more informed clinical decisions. Achieving CE marking is a major milestone towards making newborn brain assessment accessible to more babies and clinical teams across Europe.”
Founded in 2021 as a spin-out from the INFANT Research Centre at University College Cork, CergenX has built on decades of neonatal research, combining expertise in neurophysiology, artificial intelligence, software engineering and medical device development.
The Enterprise Ireland-backed High Potential Start-Up has raised more than €11 million in dilutive and non-dilutive funding to support the development and commercialisation of its technology.
The company has also advanced its ambitions in the United States, where Wave has received Breakthrough Device Designation from the US Food and Drug Administration (FDA), recognising its potential to address a serious condition with significant unmet clinical need. CergenX said it continues to work closely with the FDA as it progresses towards US market clearance.
Following the CE Mark approval, the company will focus on expanding access to Wave across Europe while continuing its US regulatory programme.
Image at top: Sean Griffin, CTO, Geraldine Boylan, CSO, and Jason Mowles, CEO of CergenX
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