Cergenx, a medtech company based in Cork, recently reached a significant milestone by obtaining FDA approval for its revolutionary device. Designed to detect brain injuries in newborns, this innovative device uses artificial intelligence to conduct neurological assessments without requiring the intervention of a specialist. This advancement promises to transform the monitoring of infants’ brain health, enabling crucial early interventions to improve clinical outcomes. With real-time data analysis, Cergenx’s device could be a game-changer in the field of neonatal care.

The company Cergenx, based in Cork, has recently received FDA approval for its innovative device designed to detect brain injuries in newborns. This device, using artificial intelligence, allows real-time analysis of brain activity through sensors placed on the scalp. Intended for use by non-specialized healthcare professionals, it offers quick results, in just 15 minutes, and requires minimal training. This advancement aims to improve clinical decision-making and optimize care for new cohorts in neonatology by intervening earlier in the diagnosis of neurological risks.

Cergenx, the medtech from Cork, gets FDA approval for an innovative device

Cergenx, an innovative medtech company based in Cork, has recently received the long-awaited FDA approval for its new device. This revolutionary product, named Wave, is designed to detect brain injuries in newborns. With advanced artificial intelligence algorithms, this device allows healthcare professionals to analyze brain activity in real time, facilitating early and non-invasive diagnosis. By integrating these technologies, Cergenx aims to significantly improve outcomes for the most vulnerable newborns.

Key features to improve neonatal health

The Wave device from Cergenx is capable of providing results in just 15 minutes from the data collected by an EEG. This represents a significant advancement in neonatal health, where reaction time can have a crucial impact on infant health. Furthermore, it is specifically designed to be used by healthcare professionals who are not necessarily experts in neurology, making the technology accessible to a wide range of hospitals.

Impact of FDA approval on the future of Cergenx

Obtaining FDA approval represents a major turning point for Cergenx. This recognition paves the way for new opportunities for funding and collaboration with industry experts. Additionally, it may facilitate a quicker approval process for future devices that the company may develop. Researchers and practitioners hope that a rapid rollout of the Wave device in hospitals can truly transform care practices by providing early support for at-risk infants.