EMVision’s Stroke Scanner Faces Critical Usability Test in Limited Mobile Stroke Unit

A Rare Opportunity in Pre-Hospital Stroke Care

EMVision Medical Devices Ltd (ASX – EMV) has embarked on a significant clinical study to evaluate its First Responder Brain Scanner within the Melbourne Mobile Stroke Unit (MSU), one of only about 45 such units worldwide. This initiative marks a crucial step in validating a portable neurodiagnostic device designed to improve stroke diagnosis before patients reach hospital care.

The study, conducted in partnership with the Australian Stroke Alliance, Ambulance Victoria, and the Royal Melbourne Hospital, aims to assess the scanner’s usability and integration into the fast-paced workflow of pre-hospital stroke treatment. The MSU environment offers a rare, real-world setting where rapid diagnosis can translate into better patient outcomes.

Two-Stage Study Design to Refine and Validate

The clinical investigation is structured in two stages. Stage 1 focuses on enrolling 10 suspected stroke patients to evaluate the device’s usability and workflow fit within the MSU. Results from this initial phase are anticipated by the end of 2025. Stage 2 will expand data collection, pairing EMVision’s scans with standard CT imaging to refine AI algorithms that enhance stroke detection accuracy.

This approach not only tests the device’s practical application but also builds a robust dataset to support regulatory submissions, including the FDA 510(k) pathway, which is critical for commercialisation in global markets.

Addressing a Critical Gap in Stroke Diagnosis

Mobile Stroke Units equipped with CT scanners have demonstrated clear clinical benefits by enabling faster diagnosis and treatment, which improve functional outcomes for stroke patients. However, their high cost, size, and operational complexity limit widespread adoption. EMVision’s First Responder Brain Scanner aims to offer a scalable, portable alternative that could democratize access to pre-hospital stroke diagnostics.

Neurologists Prof Stephen Davis AO and Prof Geoffrey Donnan AO, co-chairs of the Australian Stroke Alliance, emphasize the study’s importance in validating this technology and paving the way for broader deployment in conventional ambulances, potentially transforming stroke care delivery.

Looking Ahead

EMVision’s CEO Scott Kirkland highlighted the study’s potential to generate critical workflow and patient data that will accelerate both clinical validation and commercial pathways. As the company progresses through this rare and high-profile study, investors and stakeholders will be watching closely for the outcomes that could redefine pre-hospital stroke diagnostics.