10112524Transforming patient management of heavy menstrual bleeding using Artificial IntelligenceClosedCollaborative R&DInnovate UKMenstrual health conditions such as endometriosis and fibroids together affect up to 1.5 billion people globally and 6.5M in the UK. A shared symptom of these conditions is heavy menstrual bleeding (HMB), defined as \>80mL loss per cycle. However there is no convenient and accurate method for both patients and clinicians to measure it. HMB can seriously affect quality of life, and is the leading cause of iron-deficient anaemia. The current gold standards of weighing pads, recalling frequency or number of changed pads, equating volume to teaspoons, or using pictorial charts, are impractical and rely on subjective bias. This makes it difficult for patients to express how much they bleed, often leading to normalisation of heavy periods. Over or underestimations of bleeding can seriously impact how clinicians understand and perceive the extent of heavy periods which can cause misdiagnosis or delays in treatment and diagnosis. As a result, billions of women are forced to silently suffer. The Joii Evaluation App is an innovative solution that has the potential to revolutionize the field of menstrual health and provide great benefits to billions of women suffering globally. Joii has developed the world's first AI-backed mobile application that provides instant quantification of period volume and clot sizes by scanning a menstrual pad. As a self-management tool, this solution aims to improve early screening, monitoring, treatment, and diagnosis of abnormal menstrual health conditions related to HMB by identifying abnormally heavy periods earlier. This quantitative metric can empower, educate, and support patients in monitoring changes to their periods, providing an objective measurement to enhance communication and decision-making with their doctors. We aim to regulate our technology as Class IIA medical device to inform clinical management for abnormal vaginal bleeding related to menstrual and non-menstrual health conditions. Innovate UK funding will be used to conduct a feasibility study to evaluate the technology and regulatory aspects of our app. The study will assess technical feasibility by examining scanner performance with real menstrual blood, individual usability and acceptability in a 5-month trial, and clinician usability and acceptability through simulated consultations. Regulatory feasibility will be evaluated through compliance assessments for patient safety, protection and privacy. By the end of this study, we aim to obtain Class I medical device regulation and validate our data protection standards, bringing us closer to a direct-to-consumer market launch.