Along with the breakthrough assignment, the FDA also accepted Wave onto its Total Product Lifecycle Advisory Program (TAP). Image credit: Shutterstock / Gorodenkoff.

The US Food and Drug Administration (FDA) has granted breakthrough device designation to CergenX’s AI-powered tool for neonatal brain scans.

The Irish startup will now be in line for prioritised review after submitting the device, called Wave. It will also be able to interact quickly with FDA experts to discuss feedback during the premarket review phase.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Along with the breakthrough assignment, the FDA also accepted Wave onto its Total Product Lifecycle Advisory Program (TAP), a scheme designed to help spur development and expedite the route to market for innovative medical devices.

CergenX’s technology uses AI to provide real-time analysis of electroencephalogram (EEG) data in newborns. The company – which spun out of the University College Cork’s Infant Centre for Maternal and Child Health Research in 2021 – says Wave accelerates evaluation and accurate reflection of a newborn’s neurological state.

CergenX states the device aims to detect brain injury in newborns, which can happen before, during, or after the birthing process. According to the company, 20% of newborns require assessment for brain injury while more than 80% of hospitals do not have the means to conduct thorough newborn neurological assessment. Whilst EEGs are the gold standard for measuring brain activity in neonates, their interpretation requires specialist training.

CergenX’s AI is trained on hundreds of babies from the INFANT Research Center, an institution based at the University of York. Algorithms transform waveform and background patterns into insights for the healthcare professional using the software. The company says that since minimal training is needed, Wave can facilitate earlier point-of-care detection of brain injury risks and faster interventions.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In a post on LinkedIn, CergenX CEO Jason Mowles said: “After months of behind-the-scenes work, securing FDA Breakthrough Device Designation for Wave is a significant step forward for CergenX,” adding that this year is shaping up to be a “transformative year” for the company and neonatal care worldwide.

Also recently awarded FDA breakthrough device designation and TAP acceptance was compatriot company FIRE1. The Dublin-based heart failure device company raised $120m, along with the FDA approvals earlier this month.

Whilst unique for newborns, CergenX is not the only company using AI for EEG analysis. US-based Ceribell has developed software to help identify seizure activity and other abnormalities. The company reported positive data from a study that showed its EEG system reduced the length of stay in intensive care units and led to fewer patients leaving with disabilities.