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 eTNS is the first medical device that has been approved by the Food and Drug Administration (FDA) for the treatment of attention deficit hyperactivity disorder (ADHD). The new treatment is available by prescription only and is indicated for children ages 7-12 years who are not on any other prescription ADHD medications.

What is this New ADHD Device?

The eTNS machine is no larger than cell phones, and it works by generating a low-level electrical pulse to the patient’s brain regions that are involved with ADHD. These pulses are delivered to parts of the brain via a wire that is connected to a small patch; this patch adheres painlessly to a child’s forehead. The only thing the child feels is a slight tingling sensation on his or her skin. Despite some mild side effects observed with eTNS, no severe or long-term adverse events from using this new device have been reported.

Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, is excited about the potential life-changing option for drug-free ADHD treatment that the eTNS brings. He explains, “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 anyone who may be worried about their child walking around with a wire attached to his or her forehead, there is good news that eliminates this potential concern: Children are not supposed 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 NeuroSigma 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 machine was put through several tightly controlled trials prior to being awarded 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 by using an ADHD rating scale that was administered by a clinician. In addition, the final results were also compared to the results of those children who had used a placebo device during the trials.

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

Common Side Effects

The FDA noted these common side effects were observed: increase in appetite, trouble with drowsiness, an increase in headaches, and clenching teeth. Just like a majority of drug-based and drug-free treatment options for many different conditions, eTNS comes with a slight risk of mild side effects, though many parents and caregivers will most likely find that the benefits of using the eTNS outweigh the risks.


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 our upcoming convention today!



Sign up for our newsletter and get emails of great content like this.

By |2019-09-19T17:03:08-04:00May 30th, 2019|

About the Author:

Experienced business leader with a proven track record of success as an entrepreneur, CEO and business unit leader. Demonstrated success at building highly effective sales and marketing teams that deliver above market returns.

10 years experience developing, launching and executing leading business management conferences. Directly involved with marketing strategy and execution for over 40 new executive-level industry events within multiple management functions and industry segments.

Deep market knowledge of management and industry trends, ability to synthesize large amounts of data, uncover new markets and produce measurable financial results.