CergenX making Waves with new FDA designation

20 Jan 2025

Image: © vitaliy_melnik/Stock.adobe.com

The University College Cork spin-out plans to closely collaborate with the FDA on device development and premarket review.

Irish neurotech company CergenX, which specialises in artificial intelligence (AI) solutions for neonatal brain monitoring, has received the Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its Wave device.

The start-up’s Wave device aims to enable hospitals to conduct “expert-level” EEG (electroencephalogram) assessments, a method to record the electrical activity of the brain – without the need for specialist resources.  According to CergenX, the device leverages “advanced AI technology” to identify newborns most at risk of brain injury, providing a 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 company said.

The FDA’s Breakthrough Device is a voluntary program for manufacturers of medical and device-led combination products that provide more effective treatment or diagnosis for life-threatening conditions. For CergenX – a University College Cork (UCC) spin-out – this designation offers collaborative opportunities with FDA experts, prioritised regulatory review and, potentially, a faster approval process.

In addition, the start-up has also been accepted into the FDA’s Total Product Lifecycle Advisory Program (TAP) which helps expedite patient access to innovative medical devices by facilitating effective communication between the drug authority and the industry.

Now, with its latest achievements, CergenX plans to collaborate with the FDA throughout the Wave device’s development and premarket review.

“Receiving the Breakthrough Device Designation and being accepted into the TAP program are significant milestones for CergenX,” said Jason Mowles, the company’s CEO.

“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.”

Founded by Mowles, Sean Griffin and Prof Geraldine Boylan in 2021, CergenX spun out of UCC’s Infant Centre for Maternal and Child Health Research.

In 2023, it was awarded €6.7m from the Department of Enterprise, Trade and Employment’s Disruptive Technology Innovation Fund to develop the non-invasive brain-monitoring device.

Don’t miss out on the knowledge you need to succeed. Sign up for the Daily Brief, Silicon Republic’s digest of need-to-know sci-tech news.

Suhasini Srinivasaragavan is a sci-tech reporter for Silicon Republic

editorial@siliconrepublic.com