The FDA approved external trigeminal nerve stimulation (TNS) in 2019 as the first non-drug device for treating ADHD, ...
The agency is currently reviewing the study findings ...
With an expiration date still more than a year away, here's what the latest details reveal.
In A Nutshell • A brain stimulation device cleared by the FDA in 2019 failed to beat placebo in a rigorous 150-participant ...
A larger trial of trigeminal nerve stimulation in children with ADHD produce results that differ from an earlier pilot study, raising new questions about its efficacy.
The first-of-a-kind brain-stimulation device approved to treat attention-deficit/hyperactivity disorder (ADHD) in the US has ...
A 150-child trial found an FDA-cleared ADHD stimulation device did not significantly reduce symptoms, raising concerns over ...
A large multicenter clinical trial led by King's College London with 150 children and adolescents has shown that a device cleared by the US FDA to treat ADHD is not effective in reducing symptoms.
KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (CING) (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform ...
Kenvue, the American company that makes Tylenol, says the U.S. Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible ...
While proven a safe method, external trigeminal nerve stimulation was nonsuperior to sham treatment as early as 4 weeks and as long as 6 months in children and adolescents with ADHD, according to data ...