• Pivotal trial to support FDA De Novo clearance of Emu device
• First sites in Australia and US activated, with more to follow
• Trial designed to demonstrate >80% haemorrhage detection sensitivity and specificity

EMVision Medical Devices Limited has announced the commencement of the Pivotal (Validation) Trial for its first commercial device, the Emu bedside brain scanner. The trial has received Australian ethics approval, and the first Australian site, The Royal Melbourne Hospital, has been activated after a successful site initiation visit and operator training. Additionally, an Emu device has been shipped to the first US site, the University of Texas Health Science Center at Houston (UTHealth) Medical School and Memorial Hermann-Texas Medical Center (TMC). The Pivotal Trial is designed to enrol 300 suspected stroke participants across 4 sites in the US and 2 sites in Australia, with the primary objective of demonstrating haemorrhage detection sensitivity and specificity of over 80%. This is a critical step in selecting the appropriate treatment pathway, as the detection of haemorrhage requires a different approach compared to ischaemic stroke. The trial is expected to have an enrolment period of 6-12 months, followed by data analysis and reporting. The clinical research organisation Vastrax, with expertise in neurovascular studies, is leading the trial, which will also have an independent Trial Steering Committee and Data Safety Monitoring Board. In parallel, EMVision will conduct a 'Continuous Innovation Study' to further develop the device's features and expand the training library for its diagnostic AI algorithms. The successful completion of the Pivotal Trial is expected to support FDA De Novo clearance for the Emu point-of-care Brain Scanner, as well as serve as the predicate device for EMVision's second commercial product, the First Responder device.

EMVision is focused on the successful completion of the Pivotal (Validation) Trial for the Emu point-of-care brain scanner, which is a critical milestone in obtaining regulatory approval and commercialising the device. The company is also working on the development of additional features and the expansion of its diagnostic AI algorithms through the Continuous Innovation Study.