CergenX secures CE mark for AI-powered newborn brain assessment
The Cork-founded MedTech company has reached a major regulatory milestone for Wave, its AI-supported neonatal EEG technology, opening the way to commercialisation across Europe.
Irish MedTech company CergenX has secured CE Mark certification under the EU Medical Device Regulation (MDR) for Wave, its AI-supported technology for assessing newborn brain activity.
Wave combines electroencephalography (EEG) with artificial intelligence to help clinicians identify abnormalities associated with newborn brain injury. The system uses four electrodes, an EEG amplifier and a tablet interface to analyse a short recording of brain activity and return an objective assessment rapidly, without requiring specialist EEG expertise at the point of care.
The regulatory milestone is significant because CE marking under the EU MDR allows CergenX to commercialise Wave across the European market. For an early-stage MedTech company, this represents the transition from product development and clinical validation into regulated market access and commercial deployment.
CergenX emerged from research at University College Cork’s INFANT Research Centre and has developed Wave around a clearly defined clinical problem: access to specialist neonatal EEG remains limited in many hospitals. The company previously received FDA Breakthrough Device Designation for Wave and has also participated in the FDA Total Product Lifecycle Advisory Program.
For NWCAM2, the story provides a strong example of the wider journey required to turn innovative health technology into a market-ready product. Advanced technology alone is not enough. Medical device companies must also address clinical validation, regulatory compliance, usability, quality systems, manufacturing readiness and the operational requirements needed to scale.
The CergenX journey demonstrates how Irish research capability, specialist clinical knowledge, AI and product development can combine to create a regulated MedTech proposition with international commercial potential.
Original article
NR Times — CergenX secures CE mark for newborn brain technology
https://nrtimes.co.uk/cergenx-secures-ce-mark-for-newborn-brain-technology/