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CergenX Neonatal Brain Monitoring Device Gains FDA 'Breakthrough Designation'

• By John K. Waters
• 01/27/2025

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Irish startup CergenX's advanced AI-powered "Wave" device for neonatal brain monitoring. The company has also been accepted into the FDA's Total Product Lifecycle Advisory Program (TAP), positioning the Wave device for accelerated development and regulatory review.

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Founded in late 2021 as a spinoff from University College Cork’s INFANT Centre for Maternal and Child Health Research, CergenX is revolutionizing newborn brain health monitoring. Led by Professor Geraldine Boylan, Jason Mowles, and Sean Griffin, the company aims to address critical gaps in neonatal care with innovative technology.

The Wave device was designed to offer real-time, non-invasive EEG monitoring, enabling hospitals to perform expert-level assessments without the need for specialist resources. By leveraging cutting-edge AI, the device identifies newborns at risk of brain injury, providing clinicians with critical insights to guide early interventions and improve outcomes for vulnerable infants.

The FDA’s Breakthrough Device Program recognizes technologies with the potential to provide more effective treatment or diagnosis for life-threatening or debilitating conditions. This designation not only validates the transformative potential of the Wave device but also provides expedited regulatory review, prioritization, and enhanced collaboration with FDA experts.

"Receiving the Breakthrough Device Designation and being accepted into the TAP program are significant milestones for CergenX," said Jason Mowles, CEO of CergenX in a statement. "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. This will be instrumental as we advance the regulatory approval process for Wave."

The TAP program further accelerates the journey by fostering early and frequent communication with the FDA, ensuring a faster and more efficient pathway to market for the Wave device. TAP also facilitates collaboration with key stakeholders, enhancing the device’s development process and prioritizing its availability to healthcare providers.

CergenX plans to work closely with the FDA throughout the development and premarket review process, the company says, to wnsure the timely availability of the Wave device to hospitals and clinicians worldwide.