CORK, Ireland —
Sept 1 2026 – CergenX, an Irish medtech company transforming early brain health through AI-powered clinical insights, has announced that its first product, Wave, has achieved CE Mark certification under EU MDR 2017/745. Wave uses EEG and artificial intelligence to provide clinicians with rapid, objective insights into newborn brain activity and abnormalities associated with brain injury.
The certification is a major milestone for CergenX, enabling the company to commercialise Wave across the European market and marking an important step towards making expert neonatal brain assessment more widely accessible.