9/24/2025
EMVision Medical Devices (ASX: EMV) has commenced a world-first pre-hospital study of its First Responder Brain Scanner, placing the company at the forefront of next-generation stroke care innovation. The trial will evaluate the scanner's performance and integration within a Mobile Stroke Unit in Melbourne — one of just 45 such units worldwide.
The two-stage study is being run in partnership with the Australian Stroke Alliance, Ambulance Victoria, and the Royal Melbourne Hospital. Stage 1 will assess usability, workflow, and safety in the Mobile Stroke Unit environment. Stage 2 will compare EMVision scan data with CT imaging to help train the company’s artificial intelligence algorithms for stroke detection.
This study follows successful testing earlier this year with the Royal Flying Doctor Service in an aeromedical setting, and now transitions EMVision’s technology into a live emergency response environment.
EMVision’s Chief Executive Officer Scott Kirkland said the study represents a critical step toward bringing portable brain imaging into mainstream clinical use.
“With limited Mobile Stroke Units globally, this is a rare opportunity to test our First Responder Brain Scanner in a real-world environment. The data we collect will help refine the device and support our regulatory and commercial plans,” Kirkland said.
MSUs are specialised ambulances fitted with CT scanners, enabling faster stroke diagnosis and treatment before a patient reaches hospital. However, they are expensive, complex, and resource-intensive. EMVision’s device offers a more scalable solution by providing portable, non-invasive neuroimaging directly in the field.
The company’s long-term vision is to equip standard ambulances with lightweight scanning devices to bring rapid stroke diagnosis to communities across urban, regional, and remote areas.
Professor Stephen Davis AO, neurologist and Co-chair of the Australian Stroke Alliance, described the study as “a really important validation step” for EMVision’s device. His colleague, Professor Geoffrey Donnan AO, noted the proof-of-principle nature of the study in setting up conventional ambulances with brain imaging in the future.
Ten patients with suspected stroke will be enrolled in Stage 1 over a three-month period, with Stage 2 to follow based on outcomes and sample size determination. Data from both stages will inform the refinement of EMVision’s AI-powered stroke detection and support FDA 510(k) clearance.
The study is part of a broader roadmap toward commercialisation, which includes multiple clinical studies to support United States market entry.
EMVision’s innovative technology — developed in Australia — aims to disrupt how stroke and other neurological emergencies are diagnosed. With global demand rising for faster, scalable medical imaging, this study could be a decisive moment in the company's evolution from research to real-world impact.