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Cork spin-out gets FDA designation for AI neonatal brain monitor

6 February 2025
By Dawn O'Shea
AI-driven neonatal brain monitoring technology developed by Irish neurotech start-up, CergenX, has received Breakthrough Device Designation by the US Food and Drug Administration (FDA), which will accelerate the development and review of the device. The designation will give Cergenx enhanced collaboration opportunities with FDA experts, along with prioritised regulatory review and the potential for a […]

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