FDA Approves Treatment Of First Medical Device For Treatment Of ADHD

US regulators have given the green light to the first medical device designed to treat Attention Deficit Hyperactivity Disorder (ADHD).

NeuroSigma's external prescription Neurosigma eTNS (Monarch Trigeminal Ner Stimulation) system is the first non-drug treatment for ADHD approved by the Food and Drug Administration (FDA). It is indicated for patients aged 7 to 12 years not taking a prescription. medication.

It is a cellphone-sized device that generates a low-level electrical impulse and connects via a wire to a small patch that adheres to the patient's forehead and delivers low-level electrical stimulation that should give the impression of a tingling sensation on the skin.

Carlos Peña, director of the Division of Physical and Neurological Medicine Devices at the FDA's Center for Devices and Radiation Health, said, "This new device provides a safe, non-drug option for the treatment of ADHD in pediatric patients with the help of stimulation, a first of its kind.

"Today's action demonstrates 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 needs." special needs.

The NeuroSigma Monarch eTNS system is designed to be used at home under the supervision of a caregiver during periods of sleep.

The FDA has reviewed the device as part of its pre-market review process de novo for devices of a new type presenting a low to moderate risk. The regulator said that, although the exact mechanism of the eTNS system is not yet known, neuroimaging studies have shown that it increases activity in brain regions recognized to play an important role in the regulation of attention, emotions and behavior.

In a placebo-controlled trial of 62 patients in moderate-to-severe ADHD, those who used the Monarch eTNS system had a statistically significant improvement in their ADHD symptoms, according to a physician-administered ADHD rating scale. , compared to those using a placebo device.

NeuroSigma, a Los Angeles-based life science company, received the CE mark in 2015 for its Monarch eTNS system for ADHD in Europe, after receiving the same approval three years earlier for its use against epilepsy drug-resistant and major depressive disorder in the adult. and children aged nine and over.