This morning the FDA granted Australian company Headsafe a 510(k) clearance for its connected headgear that is able to perform an assessment of the brain.
Named Nurochek, the system uses Visual Evoked Potential (VEP) in order to gauge brain health. When a user puts on the headgear, which includes a set of goggles, the system presents visual stimulus to the brain. As this process is taking place...
