Headsafe lands FDA 510(k) for its connected brain checkup device

This news means that the Australian company will be able to expand to the United States.
By Laura Lovett
02:00 pm

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, EEG sensors that are embedded in the device are able to record brain activity, according to the company. 

Finally, the data from that session is transmitted to a smartphone and then can be stored in the cloud. 


The new announcement means that the company can start to roll out its product to the U.S. market, thereby expanding its global footprint.

“Today’s announcement represents a historic milestone for our company, and we are eager to begin execution of our market launch in the United States,” said Dr. Adrian Cohen, CEO and founder of Headsafe. “In addition to our commercialization efforts in the U.S., we expect to accelerate our research activities to deepen the body of scientific evidence supporting the use of the Nurochek system in the management of specific neurological conditions.”


This isn’t the first connected EEG on the market. Zeto is a Santa Clara, California-based startup that created a wireless headset, which uses dry electrodes, and proprietary software. Cleared by the FDA, the headset, called the zEEG, is able to perform an EEG reading and then transfer those results onto a provider’s laptop, phone or tablet via the cloud. 

In 2015, it was reported that the U.S. Department of Defense tapped BrainScope to put its FDA-cleared Ahead 200 device into action. The device consists of a headpiece with a number of EEG leads that connect to an Android smartphone, which runs the diagnostic software. 


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