On April 19, the FDA approved the first digital medical device to treat children diagnosed with attention deficit hyperactivity disorder.
The Monarch external Trigeminal Nerve Stimulation (eTNS) System, which is the size of a cell phone, emits a low-level electrical pulse through a wire to a small patch attached to a patient's forehead, stimulating branches of the trigeminal nerve and sending therapeutic signals to parts of the brain believed to be associated with ADHD.
In a clinical trial comparing eTNS to a placebo device, subjects who used eTNS every night for four weeks experienced statistically significant improvement in their ADHD symptoms, according to the FDA.
The prescription-only eTNS system, the first non-drug ADHD treatment approved by the FDA, can be used by children between the ages of 7 and 12 who are not currently on medication for ADHD. The device is designed for home use, to be employed and monitored by a caregiver while the patient sleeps.
The FDA's approval allows NeuroSigma, a Los Angeles-based biotech company focused on developing therapies involving Trigeminal Nerve Stimulation (TNS) technology, to market the device in the U.S.
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