Scottish MedTech firm launches paediatric sleep diagnosis study

Glasgow-based MedTech firm Seluna has launched a clinical validation study with the Royal Hospital for Children to improve the diagnosis and management of childhood sleep disorders. Even after diagnosis, clinicians lack the physiological insights needed to predict which children will benefit from treatment, which often involves surgery. As a result, some children undergo unnecessary operations, while others who might benefit are overlooked. The study aims to validate Seluna’s diagnostic software as a medical device (SaMD), which is designed to interpret sleep studies via a pipeline of machine-learning algorithms to support registered polysomnographic technologists and doctors in diagnosing and managing paediatric sleep apnoea. Dr Scott Black, co-founder and chief executive of Seluna, said: “Paediatric sleep diagnostics has been underserved for too long. It’s a complex challenge, which is why existing tools weren’t built for children – until now. “This validation study will demonstrate clinical impact and make a clear statement: we’re here to set a new standard. “We’re here to innovate, drive change, and compete internationally, with backing from investors who recognise the potential of the paediatric healthcare market.” The study involves 500 anonymised patients under 18 years old and will run from now until the end of 2025. Seluna expects the validation studies to support Class I medical device classification in the UK by the end of 2026, enabling adoption across the NHS and private healthcare. This will also lay the groundwork for international expansion, with Class II FDA approval in the US targeted by the end of 2027. Seluna’s machine learning pipeline automatically scores paediatric sleep studies by identifying and classifying digital biomarkers of sleep-disordered breathing. Dr Ruth Hamilton, consultant clinical scientist at Royal Hospital for Sick Children, Glasgow, and principal investigator, said: “What makes Seluna’s approach so compelling is its focus on explainable AI. “As clinicians, we need to understand why the technology is making certain recommendations. “Seluna’s focus on interpretability builds the trust we need to confidently use this technology in clinical practice. “It will help take pressure off busy departments and allow us to stop firefighting wait lists.” The validation study follows Seluna’s success in securing nearly £650,000 in funding via continued support from existing backers Gabriel Investment Syndicate, Scottish Enterprise and the University of Strathclyde, as well as a new investor STAC Invest. Angus Macfadyen, head of investment at STAC, said: “Seluna represents exactly the kind of investment opportunity STAC Invest is looking for – a world-class founding team tackling a significant global challenge with genuinely innovative technology.”