The US Food and Drug Administration (FDA) has permitted marketing of the Brainsway Deep Transcranial Magnetic Stimulation (TMS) System for treatment of obsessive compulsive disorder (OCD). OCD is typically treated with medication, psychotherapy, or a combination of the 2. According to the National Institute of Mental Health, about 1% of US adults had OCD in the past year. The FDA permitted marketing of the Brainsway device to Brainsway Ltd., with US headquarters in Hackensack, NJ.
TMS is a procedure that uses magnetic fields to stimulate nerve cells in the brain. The FDA permitted marketing of TMS as a treatment for major depression in 2008 and expanded the use to include TMS for treating pain associated with certain migraine headaches in 2013.
Adverse reactions: The most frequent adverse reaction was headache reported by 37.5% of the patients who received the Brainsway device and by 35.3% of the patients who received the sham treatment. No serious adverse reactions related to the Brainsway device were reported. Other adverse reactions, such as application site pain or discomfort, jaw pain, facial pain, muscle pain, spasm or twitching, and neck pain, were reported as either mild or moderate and resolved shortly after treatment.
FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder. [news release]. Hackensack, NJ: Brainsway Ltd. August 17, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm617244.htm?utm_campaign=08172018_PR_transcranial%20magnetic%20stimulation&utm_medium=email&utm_source=Eloqua. Accessed August 21, 2018.
This Week's Must Reads
Must Reads in FDA Actions
FDA Approves Cassipa for Opioid Addiction Treatment , FDA news release; 2018 Sep 7
FDA Approves Marketing of OCD Treatment Device, FDA Web site; 2018 Aug 17
FDA Approves Perseris for Schizophrenia, FDA news release; 2018 Jul 27
FDA Approves New Dosing Formulation for Nuplazid, Acadia Pharmaceuticals Inc. news release; 2018 Jun 29
FDA Approves Initiation Drug for Schizophrenia, Alkermes plc news release; 2018 Jul 2