CergenX's Wave Device Granted FDA Breakthrough Device Designation

CergenX, a pioneering Irish neurotech company specialising in AI solutions for neonatal brain monitoring, is pleased to announce 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). Founded by Prof Geraldine Boylan, Jason Mowles, and Sean Griffin in late 2021, CergenX is a spinout from University College Cork’s INFANT Centre for Maternal and Child Health Research.

The CergenX Wave device is set to redefine newborn brain health, enabling hospitals to conduct expert-level EEG assessments without the need for specialist resources. Leveraging advanced AI technology, the Wave device identifies newborns most at risk of brain injury, providing a critical tool for early detection and intervention in neonatal care. With its real-time, non-invasive monitoring capabilities, the Wave device aims to enhance clinical decision-making and improve outcomes for vulnerable neonatal populations.

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. By granting Breakthrough Device Designation, the FDA formally recognises that a novel device in development warrants expedited access for patients. This designation provides CergenX with enhanced collaboration opportunities with FDA experts, prioritised regulatory review, and the potential for a faster approval process.

CergenX's acceptance into the FDA's Total Product Lifecycle Advisory Program (TAP) marks another significant milestone. The FDA defines TAP as a program to help spur more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health. TAP’s primary goal is 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.

"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.

For more information about CergenX and the Wave device, please visit www.cergenx.com.