Medical neurotechnology company BrainScope has received approval from the US Food and Drug Administration (FDA) for its Ahead 100 device, for adjunctive assessment of traumatic brain injury (TBI).
By using electroencephalograph (EEG), Ahead 100 is said to provide an interpretation of the structural condition of the patient’s brain after head injury.
The device is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head computerized tomography (CT) scan, but should not be used as a substitute for a CT scan.
According to the company, Ahead 100 can also be used for patients who sustained a closed head injury within 24 hours, clinically present as a mild (TBI).
BrainScope president and CEO Michael Singer said: "FDA clearance of our Ahead 100 represents a major achievement in BrainScope’s mission to create an objective, non-invasive, patient-friendly assessment device for rapid and easy use in emergency settings.
"We are particularly grateful for the continuing strong partnership with the Department of Defense. Given our extensive clinical studies, we have maintained long-term relationships with many clinical sites, for which we are appreciative."
BrainScope has secured around $27m worth DOD research contracts for the development of its TBI assessment technology.