“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.”
“HeadsafeIP Pty Ltd, a privately held brain health technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its NUROCHEK system for brain assessment and will immediately begin commercialization activities in 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.
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.
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.”
News in Context:
- Free webinar next Tuesday, May 19th, on neurotech and wearables for brain health
- New report: Empowering 8 Billion Minds via Ethical Development and Adoption of Neurotechnologies
- Infographic on the Digital Brain Health Market 2012–2020
- Five reasons the future of brain enhancement is digital, pervasive and (hopefully) bright
- Ten neurotechnologies about to transform brain enhancement & health
- 10 highlights from the 2019 SharpBrains Virtual Summit