10052839PreemieClosedCollaborative R&DInnovate UK**Every year 15 million infants are born preterm** (before 37 weeks of gestation). Prematurity is the leading cause of mortality in children under five, and can result in devastating diseases (e.g. Necrotising Enterocolitis), and long-term sequelae such as visual and hearing problems, asthma, diabetes. Besides the tremendous impact on the quality of life of preterm infants and their families, the economic burden for the whole society is huge (annually £3b in the UK). **Nutrition is critical for improving preterm infants' health.** Since they have special nutritional needs, neonatologists fortify the milk with specific nutrients. However, the macronutrient content of breastmilk can drastically change based on many factors, even the time of the day. Currently neonatologists add a standard amount of fortifiers to milk, regardless of the nutritional content in human milk. The result is that up to 58% of preterm infants experience undernourishment and postnatal growth restriction. The practice of **targeted fortification** would ensure optimal nutrition, since it allows doctors to analyse the human milk and add the recommended dose of fortifiers for each infant. Unfortunately, NICUs do not perform human milk analysis due to the lack of affordable, easy-to-use, rapid human milk analysers. **Preemie aims at unleashing the clinical adoption of targeted fortification**, thanks to a unique combination of NIR-spectroscopic sensors, our Artificial Intelligence (AI) engine, and dedicated software. The Preemie sensor analyses human milk through simple and fast operations, requiring no consumables, while the Preemie Tracker software suggests the fortification based on milk's composition, and tracks nutrition and growth over time, so as to make data-driven decisions. **The use of AI is the main innovation over the traditional statistical methods used by competitors.** Traditional methods use only a few wavelengths of the spectrum, while AI finds and uses all the relevant data in the entire spectrum to build predictive models that can be re-tuned and improved with further data. The strength of the ML algorithms lies their capabilities to discover highly complex patterns within the large amounts of data. This leads to unique features in terms of portability, ease of use, economic savings, full digital integration, data management and scalability. Preemie has already been developed and tested in terms of technical performance and accuracy during a clinical trial in 2010-2021\. The **aim of the project** is to perform the external validation and obtain the IVD medical certification in UK and EU, thus unleashing its commercialisation in both areas.