Sydney, Australia-based brain health technology company Headsafe received FDA 510(K) clearance for its Nurochek brain-function assessment system. This news means the company will be able to expand to the United States.
The NUROCHEK system is intended for use in patients aged 14 years and older as indicator of brain function and is the world’s first portable Visual Evoked Potential (VEP) testing system for use at the point-of-care, reports Yahoo News.
The NUROCHEK system is a portable brain assessment device that provides an objective measure of brain function that utilizes VEPs. In under 3 minutes, the NUROCHEK system captures and transmits VEP stimulated Electroencephalography (EEG) data to a smartphone application for processing and secure cloud storage.
“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.”
Visual evoked potentials are used as a neurological testing modality to assess optic function pathway from the eyes via the optic nerve to the visual cortex of the occipital lobe. VEP response abnormalities have been linked to a number of neurological diseases including multiple sclerosis, ocular hypertension, diabetes, and traumatic brain injury.
Headsafe is a brain health technology company focused on delivering technologies to optimize the measurement and management of neurological disease. The company’s NUROCHEK portable brain assessment system is cleared for use in the United States and will become available in other regions subject to regulatory approvals.