EMVision emu™ Brain ScannerDiagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients

Inclusion Criteria:

1. Adults ≥22 years of age
2. Observable acute neurological deficit suspected to be stroke and within 24 hours of symptom onset
3. The use of the EMVision emu™ Brain Scanner will not delay the treatment of the patient
4. CT or MRI brain imaging following clinical evaluation per standard of care
5. Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner -

Exclusion Criteria:

1. Has received treatment for current (suspected) stroke event prior to initial CT/MRI scan OR EMVision emu™ Brain Scanner scan (such as thrombolysis)
2. In-patient for a neurological condition prior to suspected stroke onset
3. In-patient in intensive care unit prior to suspected stroke onset
4. Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography
5. Presence of any implanted electro-stimulating devices in the head and neck
6. Presence of any metallic implants in the cranial vault or surrounding bones/tissue (Note that metallic objects distant from the scan area, such as dental implants, nasal piercing etc., are acceptable)
7. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device
8. Inability to wear the investigational device (skin lesions on scalp, obvious recent blunt or penetrating injury to head, previous intracranial surgeries, neck injury etc.)
9. Unable to lie still for the duration of the scan
10. Pregnant or breastfeeding
11. Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment -