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The FDA gives green light to the first medical device for the treatment of ADHD in children



The Food and Drug Administration (FDA) approved the first medical device for the treatment of hypertensive childhood hyperactivity disorder, or ADHD, on Friday. a low level of electrical impulse to the patch located on the forehead, which interacts with the parts of the brain responsible for the symptoms of ADHD.

"This new device offers a safe, non-pharmacologic option for the treatment of ADHD in pediatric patients through the use of the first of its kind as a nerve stimulator," Carlos Peña, Director of the Department of Neurological and Physical Devices at the Center for Devices and Radiological Health & I am FDA, says the statement.

is committed to working with device manufacturers to promote the development of child health devices so that children have access to innovative, safe and efficient medical devices that meet their unique needs. " 9659002] A device called the external stimulus system of the monkey's trigeminal nerve (eTNS) is sold by NeuroSigma and is available only on prescription and is subject to monitoring.

eTNS, designed for placement in a pocket, wired with a plaster that is placed on the forehead during sleep and delivers a "sting" electrical impulse to the branches of the trigeminal nerve.

"Although the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain areas that are known to be important for the regulation of attention, emotions and behavior," the FDA said.

FDA also tested 62 children with ADHD in which the group using eTNS had "a significant improvement" in its symptoms, as opposed to another group that used placebo.

Side effects of treatment include drowsiness, increased appetite, sleeping problems, dental compression, headache and fatigue ue. The device should not be placed near the phone or used by children on an insulin pump, pacemaker or implanted neurostimulator, according to the FDA.

The FDA has not detected any serious side-effects associated with eTNS. at an insurance price and has a price of just over $ 1

,000 for the starter kit, according to the NeuroSigma website.


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