Portable brain assessment device by Headsafe secures 510(k) FDA clearance


FDA Clears Nurocheck, Portable Device to Quick­ly Assess Brain Health (MS News Today):

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.”

The Announcement:

Head­safe Announces FDA Clear­ance and U.S. Launch of its NUROCHEK™ Portable Brain Assess­ment Sys­tem (press release):

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:

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SHARPBRAINS es un think-tank y consultoría independiente proporcionando servicios para la neurociencia aplicada, salud, liderazgo e innovación.

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