Abstract 073: Validation of the EMVision emu™ Brain Scanner for Intracranial Hemorrhage Detection in Suspected Stroke: Protocol for an International Diagnostic Performance Study
Background Rapid stroke type identification is essential for time‐sensitive interventions, yet timely neuroimaging remains limited, especially in pre‐hospital and resource‐constrained settings. The EMVision emu™ Brain Scanner is a portable neurodiagnostic device using non‐ionizing electromagnetic signals to distinguish stroke subtypes. In an Australian prevalidation study enrolling 277 suspected stroke patients, it demonstrated diagnostic accuracy with sensitivity and specificity of 92% and 85% for hemorrhagic and 95% and 80% for ischemic strokes, respectively. Case studies and image reconstructions provided (figures 1 and 2). This follow‐up study aims to validate the diagnostic performance of emu™ for detecting intracranial hemorrhage in an international cohort, targeting ≥80% sensitivity and specificity. Methods A prospective, multi‐center, international, paired diagnostic accuracy study, with 4 US sites and 2 Australian sites. It will enroll 300 patients presenting within 12 hours of stroke onset. Patients will be stratified into two arms: intracranial hemorrhage, and ischemic stroke, TIA, or stroke mimic. Participants will undergo standard imaging, followed by non‐invasive scan by the emu™ device. Ground‐truth diagnoses will be adjudicated by a blinded expert panel. The primary endpoints are the sensitivity and specificity of the emu™ device for detecting hemorrhage, calculated against the reference standard. Statistical inference will rely on whether the lower bound of the 95% confidence interval for sensitivity and specificity exceeds 80%. Results First Australian and US enrollments occurred on June 11, 2025, and July 3, 2025, respectively. Latest progress in the study will be presented at the time of conference. Conclusion This is the first international validation study of a portable electromagnetic brain scanner for intracranial hemorrhage detection; a novel, non‐ionizing, diagnostic tool that can revolutionize acute stroke triage, enabling earlier treatment decisions, improved workflows, and equitable access to neuroimaging. image image
First stroke incidence, causes, treatments, and outcomes for Aboriginal Peoples in South Australia and the Northern Territory: a pilot prospective study
AbstractObjectiveWe performed a pilot stroke incidence study, focused on feasibility and inclusion of the CONSIDER reporting guidelines, to model the design of a future population‐based study aiming to definitively determine stroke incidence, antecedents, treatment, and outcomes.Study designProspective stroke incidence study (pilot study).Setting, participantsAll people aged 15 years or older who lived in postcode‐defined areas of South Australia and Northern Territory (885 472 people, including 45 127 Aboriginal people [5.1%]) diagnosed with stroke for the first time during 1 October – 31 December 2015 and admitted to public hospitals or stroke and transient ischaemic attack clinics.Main outcome measuresFeasibility of a prospective population‐based stroke incidence study.ResultsOf the 123 participants with first strokes, ten were Aboriginal (8%); the median age of Aboriginal people was 45 years (interquartile range [IQR], 33–55 years), of non‐Indigenous people 73 years (IQR, 62–84 years). For Aboriginal people, the age‐standardised incidence of stroke was 104 (95% confidence interval [CI], 84–124) per 100 000 person‐years, for non‐Indigenous people 33 (95% CI, 22–44) per 100 000 person‐years. We found that a prospective population‐based stroke incidence study in Aboriginal people was feasible, including with respect to establishing an adequate sample size, diagnostic confirmation, identification of incident stroke, confirming stroke subtypes, establishing a stable statistical population, standardising data reporting for comparison with other stroke incidence studies, and ethical research reporting that conforms to CONSIDER guidelines.ConclusionsA larger, population‐based study of the incidence of stroke in Aboriginal people is both feasible and needed to provide robust estimates of stroke incidence, antecedents, treatments and outcomes to help guide strategies for reducing the risk of and outcomes of stroke in Aboriginal people.