Every year, over a million newborns face brain injuries.

Additionally, detecting and testing issues aren’t always accessible to everybody. An Irish medtech company, CergenX, received a certification in Europe for its first product, Wave, which uses artificial intelligence to get rapid insights into a newborn’s brain activity. The CE Mark certification enables CergenX to integrate Wave into European hospitals.

Testing Brain Injuries

Photo: CergenX

Doctors usually rely on EEG’s to analyze a newborn’s brain. However, 80% of hospitals worldwide lack the resources, such as equipment or specialists, to read the results.

Wave aims to provide a solution. Developers say it uses four electrodes, an amplifier, and a tablet. It records brain activity for 10 minutes, then AI reviews the data, and gives clinicians a result in only 30 seconds.

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All About Timing

For injured newborns, early answers are critical. One effective treatment, therapeutic hypothermia, must begin within six hours of birth. Wave acts as a clinical decision-support tool to help doctors decide quickly if a baby needs to be moved to a specialist center.

“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,” Jason Mowles, Co-Founder and CEO of CergenX, said. “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.”

Professor Geraldine Boylan, Co-Founder and Chief Scientific Officer of CergenX, added, “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.”

With U.S. FDA Breakthrough Device Designation already secured, CergenX is pushing for US clearance while launching across Europe.