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.