BrainScope One
BrainScope
A handheld device using EEG-derived features to assess the likelihood of a structural brain injury visible on CT following mild head trauma.
At A Glance
- Manufacturer
- BrainScope
- Medical specialty
- Neurology
- Clearance route
- 510(k)
- Year authorized
- 2016 onward
- Modality
- EEG
- Role in workflow
- Clinical decision support
The target is not the injury. It is the CT scan. Most head CTs ordered for mild trauma are negative, and the clinical question is which patients can safely skip imaging. A device that answers that reduces radiation and cost without needing to diagnose anything.
Where It Is Used
- Mild traumatic brain injury assessment
- CT decision support in emergency departments
- Head injury triage where imaging access is limited
Limitations Worth Knowing
The assessment addresses structural injury visible on CT and does not exclude concussion, which by definition has no CT correlate. Clinical decision rules already perform reasonably well in this space, so the marginal benefit over an existing rule is the number worth asking about.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.