Cork medtech company Cergenx has secured the support of US regulators for a device that allows maternity hospital staff to detect brain injury in newborns without having to wait for specialist neurological support.
The company’s Wave device uses artificial intelligence to enable real-time analysis of data from an EEG (electroencephalogram), which records brain activity using sensors attached to the scalp.
It is designed to be used by healthcare professionals who are not specialists in the area, the company says, adding that it can deliver results within 15 minutes and requires minimal training.
By helping to identify newborns most at risk of brain injury in a non-invasive way, Cergenx says the device aims to enhance clinical decision-making and improve outcomes for vulnerable neonatal populations.
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The United States’s Food and Drug Administration (FDA), which regulates all medicines and medical devices in this key market, has now granted Breakthrough Device Designation for the Wave device. Cergenx has also been accepted into the FDA’s Total Product Lifecycle Advisory Programme (Tap).
Founded by Prof Geraldine Boylan, Jason Mowles, and Sean Griffin in late 2021, the neurotech start-up is a spin-out from University College Cork’s Infant Centre for Maternal and Child Health Research, focusing on artificial intelligence solutions for neonatal brain monitoring.
The FDA’s Breakthrough Device Programme is designed to accelerate the development and review of medical devices that offer more effective treatment or diagnosis for life-threatening or debilitating conditions.
It will give Cergenx enhanced collaboration opportunities with FDA experts, prioritised regulatory review and the potential for a faster approval process.
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Acceptance into the Tap programme is also significant, the company said. The FDA established the programme in October 2023 to accelerate development of high-quality, safe, effective and innovative medical devices that are critical to public health. It is currently working with the developers of just 65 devices.
“Receiving the Breakthrough Device Designation and being accepted into the Tap programme are significant milestones for CergenX,” said Mr Mowles, chief executive 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.”
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.
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