CergenX has secured a CE mark for Wave, its AI-supported technology designed to assess newborn brain activity using EEG.
The certification under EU MDR 2017/745 allows the Irish medtech company to commercialise the product across the European market.
Wave combines electroencephalography, or EEG, with artificial intelligence to give clinicians information about newborn brain activity and abnormalities associated with brain injury.
More than one million newborns worldwide are affected by brain injury each year, while more than 80 per cent of hospitals worldwide are unable to provide EEG.
The device uses four electrodes, an EEG amplifier and a tablet interface to analyse 10 minutes of newborn brain activity.
According to CergenX, its AI technology can return a simple result in as little as 30 seconds, giving clinicians an objective assessment of neonatal brain function and EEG abnormalities linked to known markers of brain injury.
The technology is designed to provide expert-level EEG assessment without requiring specialist EEG interpretation.
Jason Mowles, co-founder and chief executive of CergenX, said: “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.”
For newborns affected by brain injury, early identification can be critical. Therapeutic hypothermia, one of the most effective interventions for certain forms of newborn brain injury, must begin within six hours of birth to achieve the best outcomes.
Earlier identification can also help clinicians determine which infants require specialist intervention or transfer to a centre able to provide additional care.
Wave is designed as a clinical decision-support tool, providing clinicians with an objective assessment to support, rather than replace, clinical decision-making.
Professor Geraldine Boylan, co-founder and chief scientific officer of CergenX, said: “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.”
CergenX was founded in late 2021 as a spin-out from the INFANT Research Centre at University College Cork, building on decades of neonatal research and expertise in neurophysiology, artificial intelligence, software engineering and medical device development.
The Enterprise Ireland-backed company has since raised more than €11m in dilutive and non-dilutive funding to support the development and commercialisation of its technology.
Wave has also received Breakthrough Device Designation from the US Food and Drug Administration, and CergenX is continuing to work towards US market clearance.
Following the CE mark, the company plans to expand market access across Europe while continuing its US regulatory pathway.
