Delivering cost-effective, accurate and accessible heart disease diagnostics: Evidencing the clinical validity of the LightScope Technology

Heart disease, responsible for 25% of preventable deaths, is often detected too late.(1) At-risk groups such as women and ethnic minorities face higher misdiagnosis rates and poorer outcomes due to limited access to early diagnosis.(2-9) The NHS Darzi review emphasized the importance of prevention, early diagnosis, and utilizing new technologies to shift care closer to home. The Minister for Public Health reinforced this by stating, "We know so many deadly diseases can be avoided if we seek help in enough time."(10) To address this critical issue, LightHearted AI has developed the LightScope---a contactless optical stethoscope that uses laser technology and AI to rapidly capture heart sounds, ECG, respiration rates, and blood pressure from one single body location in 10 seconds. This device then provides an instantaneous AI-assisted diagnosis for several conditions, offering greater accuracy than traditional methods. Our initial focus is on diagnosing aortic stenosis (AS), a growing global health issue. In the UK, heart valve diseases like AS affect over 1.5 million people, with many cases going undiagnosed. Without timely intervention, AS can lead to heart failure and death.(11) LightScope's innovative approach offers a non-invasive, fast, and reliable method to detect AS, addressing the limitations of current diagnostic tools. We will conduct a UK-based clinical validation trial involving 400 patients to validate the safety and effectiveness of LightScope in diagnosing AS. The trial will generate the final piece of evidence for CE marking (Class IIA) submission and pave the way for commercialisation within the NHS, as well as adoption by remote patient monitoring and telehealth companies. Beyond AS, LightHearted AI plans to develop and expand its AI algorithms to diagnose other heart conditions including congenital heart disease, prosthetic heart valve monitoring, ischaemic heart disease and heart failure using a proprietary dataset from over 3,000 patients. Securing funding will help advance this mission, to improve early detection and hence outcomes, reduce healthcare disparities, and accelerate LightScope's route to market. LightScope's potential to transform cardiac care is vast. By enabling early diagnosis this technology will reduce unnecessary hospitalisations and improve patient outcomes, particularly for marginalised groups. Additionally, LightScope supports the decentralisation of care by enabling diagnosis in community settings, making it a cost-effective solution for overburdened healthcare systems.