FDA Clears Nurocheck, Portable Device to Quickly Assess Brain Health

A portable device that can quickly measure electrical activity in the brain and relay it to doctors via a smartphone app, called the Nurochek system, has been cleared by the United States Food and Drug Administration (FDA) for use as a medical device.

Its developer, Headsafe, plans to it soon make this brain assessment system available for use with patients in the U.S., ages 14 and older.

“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,” Adrian Cohen, CEO and founder of Headsafe, said in a press release.

Nurochek works by measuring visual evoked potential (VEP), the electrical signals that go from the eyes to the brain. When light hits the eyes, it activates specialized light-sensing cells, called photoreceptors. Electrical signals are sent from these cells in the eye to regions of the brain (most notably the visual cortex), where the signals are processed and ultimately translated into images.

The system includes a headset worn over the eyes, which connects to a smartphone via an app to transmit data to remote online processing and storage sites known as the cloud. A particular visual stimulus is given the eyes, and then electroencephalography (EEG) measures the resulting electrical signal from the eye to the brain. The measured EEG data are transmitted for processing and secure cloud storage, Headsafe reports on its website, with the entire process taking about three minutes.

Measuring VEP is useful because it can indicate how well neurons — the cells that transmit electrical signals within the nervous system — are functioning within parts of the brain responsible for vision. Abnormalities in VEPs have been associated with  conditions that affect the nervous system, including multiple sclerosis, ocular hypertension, diabetes, and traumatic brain injury.

Specifically, the FDA gave the Nurochek system 510(k) clearance, required for commercial use of medical devices in the U.S.

The company plans to conduct further research into its use on people with MS and other nervous system disorders.

“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,” Cohen added.

Headsafe was founded in Sydney in 2017.