FDA gives green light to ADHD medical device
NeuroSigma’s prescription-only Monarch external Trigeminal Nerve Stimulation (eTNS) System is the first non-drug treatment for ADHD to be approved by the FDA and is indicated for patients aged 7 to 12 who are not taking a prescription ADHD medication.
The device, which is approximately the size of a mobile phone, generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient’s forehead and delivers a low-level electrical stimulation that should feel like a tingling sensation on the 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 paediatric 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 paediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”
NeuroSigma’s Monarch eTNS System is intended to be used in the home under the supervision of a caregiver during periods of sleep.
The FDA reviewed the device through its de novo premarket review pathway for low- to moderate-risk devices of a new type. The regulator said that, while the exact mechanism of eTNS is not yet known, neuro-imaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behaviour.
In a 62-patient placebo-controlled trial in moderate to severe ADHD, those using the Monarch eTNS System had statistically significant improvement in their ADHD symptoms, as judged by a clinician-administered ADHD rating scale, compared with those using a placebo device.
NeuroSigma, a Los Angeles-based life sciences company, received a CE mark in Europe in 2015 for its Monarch eTNS System in ADHD, having received the same approval three years earlier for the system’s use against drug-resistant epilepsy and major depressive disorder in adults and children aged nine and older.