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FDA clears use of EEG-based ADHD test

human-brain-biometricsFirst ADHD brain wave test approved by FDA (CBS News):

Diag­nos­ing some­one with atten­tion deficit hyper­ac­tiv­ity dis­or­der (ADHD) is often a tricky sci­ence because it relies heav­ily on psy­chi­atric and behav­ioral exam­i­na­tions. For the first time, the Food and Drug Admin­is­tra­tion has approved a device that could aid doc­tors by pro­vid­ing phys­i­cal evi­dence for diagnosis…The Neu­ropsy­chi­atric EEG-Based Assess­ment Aid (NEBA) Sys­tem is the first med­ical device of its kind to help diag­nose the neu­robe­hav­ioral dis­or­der in chil­dren and teens. It uses an elec­troen­cephalo­gram (EEG) test to look at the patient’s brain waves.”

FDA announce­ment, FDA per­mits mar­ket­ing of first brain wave test to help assess chil­dren and teens for ADHD:

The U.S. Food and Drug Admin­is­tra­tion today allowed mar­ket­ing of the first med­ical device based on brain func­tion to help assess attention-deficit/hyperactivity dis­or­der (ADHD) in chil­dren and ado­les­cents 6 to 17 years old. When used as part of a com­plete med­ical and psy­cho­log­i­cal exam­i­na­tion, the device can help con­firm an ADHD diag­no­sis or a clinician’s deci­sion that fur­ther diag­nos­tic test­ing should focus on ADHD or other med­ical or behav­ioral con­di­tions that pro­duce symp­toms sim­i­lar to ADHD…The NEBA Sys­tem is a 15– to 20-minute non-invasive test that cal­cu­lates the ratio of two stan­dard brain wave fre­quen­cies, known as theta and beta waves. The theta/beta ratio has been shown to be higher in chil­dren and ado­les­cents with ADHD than in chil­dren with­out it…The FDA reviewed the NEBA Sys­tem through the de novo clas­si­fi­ca­tion process, a reg­u­la­tory path­way for some low– to moderate-risk med­ical devices that are not sub­stan­tially equiv­a­lent to an already legally mar­keted device.”

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    Categories: Attention and ADD/ADHD, Cognitive Neuroscience, Health & Wellness, Technology

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