Seluna builds a machine-learning software-as-a-medical-device (SaMD) that automatically scores paediatric sleep studies by identifying and classifying digital biomarkers of sleep-disordered breathing. Its pipeline is designed to be interpretable and transparent so it supports—rather than replaces—clinical judgement, aiming to reduce clinical workload and standardise diagnostics. The company has launched a major clinical validation study with the Royal Hospital for Children in Glasgow involving 500 anonymised patients running through the end of 2025. Seluna plans a broader multi-site validation programme with additional NHS sites expected to join by year-end to capture a diverse UK population and minimise model bias. Management says the validation studies will support Class I medical device classification in the UK by end of 2026 and lay groundwork for Class II FDA approval in the US by end of 2027, enabling NHS adoption and international expansion. Financially, Seluna recently secured nearly £650,000 in continued funding from existing backers and a new investor to support the validation programme.

Total raised

$1M

Funding rounds

1

Latest round

Equity

Latest activity

Aug 2025