Neolook Solutions achieves CE marking for Cry Detection AI as first AI-as-SaMD under EU MDR

Neolook Solutions B.V. has received CE marking for its Cry Detection AI as a Software as a Medical Device under EU MDR 2017/745 – the first CE-certified AI cry detection technology in the world. The Declaration of Conformity was issued by Neolook Solutions B.V. on 9 August 2024 for Cry Detection AI, classified as Class I under the EU MDR self-declaration pathway, authorising commercial deployment across EU/EEA markets. This achievement is the Regulatory Capstone of the Cry AI lineage – the formal close of a clinical cycle that began with bedside engagement at Radboudumc – Beatrix Kinderziekenhuis in Nijmegen. Three iterative clinical study cycles produced the labelled dataset and clinical investigation report lodged in the Technical File, alongside an algorithm lock-file and post-market surveillance plan. Neolook holds the first CE certification for AI cry detection in the world under EU MDR 2017/745.