FDA Approves First Medical Device for ADHD Treatment Options

FDA Approves First Medical Device for ADHD Treatment Options

The New ADHD Machine Delivers Promising Trial Results

The realm of FDA-approved ADHD treatment options so far has been less than hopeful in the eyes of many, especially for frustrated children diagnosed with the condition and their caregivers. However, hope got a little push in April 2019 when regulators approved NeuroSigma’s Monarch external Trigeminal Nerve Stimulation (eTNS). The new treatment is available by prescription only, and is indicated for children ages 7-12 who are not on any other prescription medication for attention deficit hyperactivity disorder (ADHD).

What is this New ADHD Device?

The eTNS is the size of a cellular phone, and it generates an electrical pulse at low levels to the patient. These pulses are delivered via a wire connected to a small patch that adheres to a child’s forehead. The only thing the child feels is a tingling sensation on his or her skin.

Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said, “This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind. Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”

For those worried about a child walking around with a wire attached to the forehead, there is no need to worry; children are not to use the device all the time. In fact, they are not to use it at all while they are awake. The new Monarch ADHD device by NeroSigma is designed to be used at the child’s home under a caregiver’s supervision, and only while he or she is sleeping.

Tests and Trials for the Monarch External Trigeminal Nerve Stimulation Device

The eTNS was put through several trials prior to FDA approval, one of which was a placebo-controlled trial for 62 patients who have moderate to severe ADHD. The results of the trial showed that those children who were using NeuroSigma’s device responded with statistically significant improvements in their ADHD symptoms. These results were determined using an ADHD rating scale administered by a clinician, and were also compared to those children who used a placebo device.

Furthermore, the FDA regulator in charge of approval stated that although the exact mechanism of the eTNS was not yet known at the time through its de novo premarket review for low- to moderate-risk devices of a new type, neuro-imaging studies did show that the device successfully increases brain activity in the regions that are important in regulating emotion, behavior, and attention.


NeuroSigma is a life sciences company based in Los Angeles that has received many accolades and approvals for its revolutionary ADHD treatment options and more. It earned a CE mark in Europe back in 2015 for its Monarch eTNS system for ADHD. In addition, it had received the same approval in 2012 for the Monarch’s use as a treatment for major depressive disorder and drug-resistant epilepsy in children and adults above the age of nine.

Be sure to stay up to date with all the latest news and developments in ADHD treatment options; reserve your seat at on of our upcoming pharma conferences today!


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By |2019-06-20T20:49:38+00:00May 30th, 2019|

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Byron Mignanelli

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