Sept 1 2026 – CergenX, an Irish medtech company transforming early brain health through AI-powered clinical insights, has announced that its first product, Wave, has achieved CE Mark certification under EU MDR 2017/745. Wave uses EEG and artificial intelligence to provide clinicians with rapid, objective insights into newborn brain activity and abnormalities associated with brain injury.
The certification is a major milestone for CergenX, enabling the company to commercialise Wave across the European market and marking an important step towards making expert neonatal brain assessment more widely accessible.
More than one million newborns worldwide are affected by brain injury each year. Electroencephalography (EEG) is considered the gold standard for assessing the newborn brain, yet access to EEG and the expertise required to interpret it remains limited, with more than 80% of hospitals worldwide unable to provide it.
CergenX Wave has been developed to help address this critical unmet need.
Using four electrodes, an EEG amplifier and a tablet interface, Wave analyses 10 minutes of newborn brain activity. The data is evaluated using CergenX’s proprietary AI technology, returning a simple result in as little as 30 seconds.
Crucially, the technology is designed to deliver expert-level EEG assessment without requiring specialist EEG interpretation, helping clinicians access 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, 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 capable of providing 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.”
From Irish research to international markets
CergenX was founded in late 2021 as a spin-out from the INFANT Research Centre at University College Cork (UCC), building on decades of neonatal research and bringing together expertise in neurophysiology, artificial intelligence, software engineering and medical device development.
The Enterprise Ireland-backed High Potential Start-Up has since raised more than €11 million in dilutive and non-dilutive funding to support the development and commercialisation of its technology.
The company has also made significant progress in the US. Wave received Breakthrough Device Designation from the US Food and Drug Administration (FDA), recognising its potential to address a serious condition where significant unmet need exists. CergenX continues to work closely with the FDA as it advances towards US market clearance.
With CE Mark certification now achieved, CergenX will focus on expanding market access across Europe while continuing to progress its US regulatory pathway.
CergenX is an Irish medtech company transforming brain health through AI-powered clinical insights. Founded in 2021 as a spin-out from the INFANT Research Centre at University College Cork, CergenX combines expertise in neonatal neurophysiology, artificial intelligence, software engineering and medical device development. Its first product, Wave, uses EEG and artificial intelligence to provide clinicians with rapid, objective insights into newborn brain activity and abnormalities associated with brain injury. CergenX is an Enterprise Ireland-backed High Potential Start-Up. Wave is CE marked and has received FDA Breakthrough Device Designation.
