Background / Aims
Stroke is a time-critical emergency in which earlier diagnosis may improve triage, treatment selection and access to specialist care. The Australian Stroke Alliance and EMVision are collaborating to advance portable brain scanning technology for earlier stroke diagnosis when conventional imaging is not immediately available. The EMVision emu™ is a non-ionising electromagnetic brain scanner designed as a preliminary tool to identify likely intracranial haemorrhage in adults with suspected stroke before definitive CT or MRI. The EMU study is a pivotal validation trial assessing diagnostic performance, safety and usability in the emergency department.
Methods
EMU is a multi-centre, prospective, consecutive, paired-diagnosis diagnostic performance study enrolling adults presenting with acute neurological deficit suspected to be stroke within 12 hours of symptom onset. Participants undergo standard-of-care neuroimaging followed by emu™ scanning within 30 minutes of initial CT or MRI, before treatment initiation. The primary objective is to demonstrate intracranial haemorrhage detection sensitivity and specificity greater than 80%. Secondary objectives include scan completion time, safety, usability and device deficiencies. Reference-standard diagnosis is determined by an independent blinded expert panel supported by a blinded core imaging laboratory.
Results
The study is actively enrolling across Australia and the United States. The emu™ scanner has been successfully implemented into emergency code stroke workflows, data quality has been verified, and recruitment is ongoing. No device-related adverse events have occurred.
Conclusion
This pivotal study represents an important step toward a portable diagnostic approach to support earlier stroke diagnosis and faster treatment decisions.