Irish MedTech company CergenX has received the US Food and Drug Administration (FDA) breakthrough device designation for its Wave neonatal brain monitoring technology.
The startup will now receive prioritised review for its Wave device. The FDA breakthrough designation also allows quick interaction with FDA experts during the premarket review phase.
Additionally, Wave has been accepted into the FDA’s Total Product Lifecycle Advisory Program (TAP), which accelerates medical device development and market access.
The company joins another Irish MedTech firm, Fire1, as a recent addition to the programme. Fire1 had raised $120m, along with securing FDA approvals earlier this month.
CergenX’s device is an artificial intelligence (AI)- powered technology that analyses newborn electroencephalogram (EEG) data in real time.
The MedTech company has designed the Wave device to enhance rapid evaluation and accurate assessment of a newborn’s neurological health.
CergenX’s device aims to detect brain injury in newborns, which can occur before, during, or after birth.
According to the Irish company, over 80% of hospitals lack the tools for comprehensive neurological evaluations, despite 20% of newborns needing brain injury assessments. EEGs are said to be the gold standard for brain activity measurement but interpreting them requires specialist training.
The AI, trained on data from the INFANT Research Centre of the University of York, analyses EEG waveforms and background patterns to provide actionable insights for healthcare professionals.
Wave is said to enable earlier detection and faster interventions for brain injury risks within 15 minutes with minimal training.
The device is intended to help identify newborns at risk of brain injury non-invasively, aiming to improve clinical decision-making and outcomes for vulnerable neonatal populations.
CergenX CEO Jason Mowles said: “Receiving the Breakthrough Device Designation and being accepted into the TAP program are significant milestones for CergenX.
“These recognitions underscore the potential of our Wave device to transform neonatal care by providing clinicians with critical, real-time insights into the neurological health of newborns and will be of significant importance as we look to advance the regulatory approval process for Wave.”
Founded in late 2021, CergenX is a neurotech firm that was spun out of University College Cork’s Infant Centre. It specialises in AI solutions for neonatal brain monitoring.
In November 2023, a CergenX-led consortium, including UCC/Infant, secured €6.7m from the Disruptive Technologies Innovation Fund to develop Wave.
