For a child struggling to breathe at night, the path to a diagnosis is often a long and analog one. It starts with a bulky, hospital-grade sleep study, the resulting data printed on reams of paper, and a specialist manually scoring events through the night. The bottleneck isn't just the hardware, it's the human interpretation. Seluna, a Glasgow-based medtech founded in 2022, is betting that an AI trained specifically on pediatric data can untangle that knot, offering clinicians a faster, more consistent read to prioritize the children who need urgent care [Perplexity Sonar Pro Brief].
The Clinical Wedge
Seluna's core product is machine learning software designed to function as a Software as a Medical Device (SaMD). Its pipeline automatically scores pediatric sleep studies by identifying and classifying digital biomarkers of sleep-disordered breathing. The company's wedge is its singular focus on children. Conventional sleep diagnostics and interpretation workflows are largely built for adults, a mismatch that can obscure or mischaracterize pediatric conditions. By training its algorithms exclusively on pediatric data, Seluna aims to provide a tool that speaks the specific clinical language of childhood sleep apnea [Perplexity Sonar Pro Brief]. The intended outcome is straightforward: reduce the time from test to treatment decision, ensuring the most severe cases are flagged immediately.
Funding a Real-World Validation
The company's most significant milestone to date is a clinical validation study launched in late 2025 at the Royal Hospital for Children in Glasgow, involving 500 patients [BioWorld, September 2026]. This real-world test is the critical next step toward regulatory clearance. To fund it, Seluna secured a seed round of nearly £650,000 (approximately $825,000) in August 2025 [Vestbee, August 2025]. The round included new investor STAC Invest and existing backers Gabriel Investment Syndicate, Scottish Enterprise, and the University of Strathclyde. By that same month, the company reported it had secured approximately £1.2 million in total dilutive and non-dilutive funding [Startup Grind Glasgow, August 2025].
| Date | Amount | Lead Investor | Key Purpose |
|---|---|---|---|
| August 2025 | STAC Invest | Fund clinical validation study and progress toward formal trials [Vestbee, August 2025]. |
The Founders and the NHS Anchor
Seluna was founded by Dr. Scott Black, CEO, and Dr. Yola Jones, CTO. Public biographies are brief, but their work is anchored in the UK's National Health Service. The company's development has been closely tied to NHS Greater Glasgow and Clyde, which provided the clinical sleep data used to train the initial algorithms [Perplexity Sonar Pro Brief]. This early collaboration is a classic, and often essential, medtech strategy: building the product within the very system that will eventually buy it. The ongoing 500-patient trial at the Royal Hospital for Children continues this embedded approach, positioning Seluna not as an outside vendor but as a development partner to the NHS.
The Path to Regulation and Revenue
For any diagnostic SaMD, the commercial and clinical journey is defined by regulatory gates. Seluna is currently in the validation phase, a precursor to seeking formal approvals from bodies like the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The company has not disclosed a timeline for regulatory submission or commercial launch. Its business model appears to be SaaS-based, targeting hospital systems and health services, but no paid deployments or revenue figures have been reported. The risks here are familiar in digital health:
- Clinical validation burden. The 500-patient study must conclusively demonstrate that the AI's interpretation matches or exceeds the accuracy of expert human scorers. A miss on sensitivity or specificity would be a significant setback [BioWorld, September 2026].
- Regulatory pacing. Even with positive trial data, the path to MHRA or CE marking is measured in quarters, not months. Commercial momentum is on hold until that clearance is secured.
- Integration workflow. The software's value is only realized if it fits seamlessly into existing hospital IT and clinician workflows. A brilliant algorithm that creates extra clicks or requires a separate login often fails to gain adoption.
Seluna's most plausible answer to these challenges is its foundational NHS partnership. By validating the tool within a major children's hospital, it is simultaneously de-risking the clinical, workflow, and eventual buyer relationships.
The Standard of Care Today
The patient population here is children with suspected obstructive sleep apnea (OSA), a condition where breathing is repeatedly interrupted during sleep. For a pediatric pulmonologist or sleep specialist today, the standard diagnostic workflow is labor-intensive. A child typically undergoes an overnight polysomnogram in a hospital lab, connected to numerous sensors. The raw data is then reviewed page by page, with a clinician manually marking apnea events, hypopneas, and oxygen desaturations. This scoring process is time-consuming, subject to interpreter variability, and contributes to long wait times for a final diagnosis and treatment plan, which may involve surgery or the use of a continuous positive airway pressure (CPAP) machine. Seluna's bet is that its AI can act as a consistent, first-pass reader of that data, highlighting critical cases for urgent review and standardizing the analysis of all others. For a health system grappling with backlogs and a family anxious for answers, shaving days or weeks off that diagnostic delay is the core of the value proposition.
Sources
- [Vestbee, August 2025] STAC Invest invests £1M in three female-led healthcare startups | https://www.vestbee.com/insights/articles/stac-invest-invests-1-million
- [Digital Health, August 2025] Scottish accelerator invests £1m in female-led HealthTech startups | https://www.digitalhealth.net/2025/08/scottish-accelerator-invests-1m-in-female-led-healthtech-startups/
- [Vestbee, August 2025] Scottish medtech firm Seluna raises €752k to revolutionise paediatric sleep apnoea diagnosis | https://www.vestbee.com/insights/articles/seluna-raises-752k
- [EU-Startups, August 2025] Scotland's Seluna dreams big (and helps kids sleep better) with nearly €752k for AI-powered diagnosis tool | https://www.eu-startups.com/2025/08/scotlands-seluna-dreams-big-and-helps-kids-sleep-better-with-nearly-e752k-for-ai-powered-diagnosis-tool/
- [BioWorld, September 2026] Seluna launches study to validate sleep diagnostic software | https://www.bioworld.com/articles/723460-seluna-launches-study-to-validate-sleep-diagnostic-software
- [Startup Grind Glasgow, August 2025] Startup Funding: Finding the Right Fit | https://www.startupgrind.com/events/details/startup_grind-glasgow-presents-startup-funding-finding-the-right-fit/
- [Tech.eu, August 28, 2025] Seluna secures £650K and launches major clinical trial for childhood sleep disorder diagnostics | https://tech.eu/2025/08/28/seluna-secures-ps650k-funding-and-launches-major-clinical-trial-for-childhood-sleep-disorder-diagnostics/