Clinical Trials

Inclusion Criteria:

• Adults ≥22 years of age.
• Presenting to hospital with acute neurological deficit suspected to be stroke and within 12 hours of symptom onset.
• The use of the EMVision emu™ Brain Scanner will not delay the treatment of the patient.
• CT or MRI brain imaging following clinical evaluation in Emergency Department per standard of care.
• Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner

Exclusion Criteria:

• Has received treatment for current (suspected) stroke event prior to initial CT/MRI scan OR EMVision emu™ Brain Scanner scan (such as thrombolysis)
• Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography.
• Presence of any implanted electro-stimulating devices in the head and neck.
• 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)
• Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device.
• Inability to wear the investigational device (skin lesions on scalp, obvious recent blunt or penetrating injury to head, previous intracranial surgeries, neck injury etc.)
• Unable to lie still for the duration of the scan.
• Pregnant or breastfeeding.
• Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/14/2025. Questions regarding updates should be directed to the study team contact.