CergenX, an Irish neurotech company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Wave device, an AI-powered solution for neonatal brain monitoring. This designation aims to expedite the development and review of the device, which is designed to enable healthcare professionals to detect brain injury in newborns more efficiently.
Wave Device: AI-Driven Neonatal Brain Monitoring
The Wave device utilizes artificial intelligence to analyze data from electroencephalograms (EEGs) in real-time. EEGs record brain activity using sensors attached to the scalp. The device is designed for use by healthcare professionals without specialized neurological training, delivering results within 15 minutes with minimal training required. CergenX reports that the Wave device can help identify newborns at the highest risk of brain injury in a non-invasive manner, enhancing clinical decision-making and improving outcomes for vulnerable neonatal populations.
FDA Breakthrough Device Program and TAP
The FDA's Breakthrough Device Program is designed to accelerate the development and review of medical devices that offer more effective treatment or diagnosis for life-threatening or debilitating conditions. The designation provides CergenX with enhanced collaboration opportunities with FDA experts, prioritized regulatory review, and the potential for a faster approval process.
CergenX has also been accepted into the FDA's Total Product Lifecycle Advisory Program (TAP). TAP aims to expedite patient access to innovative medical devices by providing early, frequent, and strategic communications with the FDA and by facilitating engagement with other key external parties for developers of devices of public health importance. As of January 2025, only 65 devices are part of the TAP program.
Executive Perspective
"Receiving the Breakthrough Device Designation and being accepted into the TAP program are significant milestones for CergenX," said Jason Mowles, Chief Executive Officer 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."
CergenX plans to collaborate closely with the FDA throughout the development and premarket review process, leveraging the benefits of both the Breakthrough Devices Program and TAP to ensure the timely availability of the Wave device to healthcare providers and patients. A Cergenx-led consortium, including UCC/ Infant, was awarded €6.7 million in funding from the Enterprise Ireland-managed Disruptive Technologies Innovation Fund to develop Wave.
