UCC and INFANT spin-out company Cergenx secures FDA support for neonatal brain injury device

20 Jan 2025

CergenX, a pioneering Irish neurotech company specialising in AI solutions for neonatal brain monitoring, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its innovative “Wave” device. Additionally, CergenX has been accepted into the FDA’s Total Product Lifecycle Advisory Program (TAP).