Headsafe Earns FDA Clearance for Brain-Assessment System
Australian developer Headsafe received marketing clearance from the FDA for its Nurochek brain-function assessment system.
The portable device measures the brain’s electrical activity in response to light. Abnormalities in responding to light have been tied to certain neurological diseases, such as multiple sclerosis, diabetes and ocular hypertension.
The Nurochek test takes less than three minutes and sends the collected data to a smartphone app.