CergenX announced the FDA granted breakthrough device designation for its Wave device for neonatal brain monitoring. Additionally, the FDA accepted the Cork, Ireland-based company into its Total Product Lifecycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. The company joins fellow Irish medtech company Fire1 as recent additions into this program.
CergenX, a spinout from University College Cork’s INFANT Centre for Maternal and Child Health Research, designed Wave to “redefine newborn brain health.” It aims to help hospitals conduct expert-level EEG assessments without the need for specialist resources.
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Leveraging AI, the device identifies newborns most at risk of brain injury. It provides a critical tool for early detection and intervention in neonatal care. The device features real-time, non-invasive monitoring capabilities to enhance clinical deicsion-making and improve outcomes.
CergenX said it plans to collaborate closely with the FDA throughout its development and premarket review process.
“Receiving the Breakthrough Device Designation and being accepted into the TAP program are significant milestones for CergenX,” said Jason Mowles, CEO at 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.”
