- The disease
- Stroke is a time-critical medical emergency that falls into two main types: ischaemic stroke, caused by a blocked artery, and haemorrhagic stroke, caused by bleeding in or around the brain (intracranial hemorrhage, or ICH). Rapid, accurate differentiation between the two types is essential because their treatments differ and giving the wrong treatment can cause serious harm. Currently, computed tomography (CT) scanning is the standard method for distinguishing ICH from ischaemic stroke, but CT requires patients to be moved to a fixed scanner, which takes time. Access to CT is limited in rural, remote, and pre-hospital settings.
- What the asset is trying to do
- The emu device is a portable, bedside electromagnetic brain scanner that uses low-power microwave signals to detect differences in the electrical properties of brain tissue, aiming to identify the presence of blood or altered tissue consistent with ICH or ischaemic stroke. Because the device does not use ionising radiation and is designed to operate at the bedside or in transport settings, it differs from CT and magnetic resonance imaging (MRI) in that it does not require the patient to be moved to a fixed imaging suite. An aeromedical study announced by EMVision in May 2026 specifically examined use cases in rural and remote environments (per ASX announcement, 26 May 2026).
- What the trial is measuring, and why it matters
- The pivotal trial (NCT06999122) is measuring the diagnostic performance of the emu scanner, specifically its ability to correctly detect intracranial hemorrhage in patients presenting with suspected stroke. An ASX announcement dated 10 May 2026 disclosed that the trial scope was expanded to also include detection of acute ischaemia. Diagnostic performance studies of this type typically report metrics such as sensitivity (ability to correctly identify patients who have the condition) and specificity (ability to correctly identify patients who do not), measured against a reference standard such as CT or MRI.
- Efficacy benchmarks in this setting
- CT imaging is the current standard of reference for ICH detection and has been reported to have sensitivity near 98% and specificity near 99% for acute ICH in the hyperacute phase (per Kidwell et al, JAMA 2004, doi:10.1001/jama.292.15.1823). MRI diffusion-weighted imaging is the established reference for acute ischaemic stroke detection. Because the emu pivotal trial is an early-stage regulatory study enrolling 300 patients (per ClinicalTrials.gov NCT06999122), any interim figures from this study are not statistically comparable to the performance data established for CT or MRI in large validated datasets.
- Commercial context
- No portable microwave-based brain scanner has received FDA clearance or approval in the United States for stroke triage as of the date of these source materials. EMVision is pursuing FDA De Novo clearance, a regulatory pathway for novel, low-to-moderate risk devices without a predicate (per ASX announcement, March 2025). EMVision received a A$3.8 million R&D tax rebate in March 2026 and a A$1.17 million instalment under an Industry Growth Programme (IGP) grant in May 2026 (per ASX announcements, 15 March 2026 and 24 May 2026). The emu device is EMVision's lead clinical asset. No licensing deal or commercial partnership terms have been publicly disclosed.