Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Marketing of OCD Treatment Device

FDA Web site; 2018 Aug 17

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. Accessed August 21, 2018.

This Week's Must Reads

MMI a Valid Tool for Cognitive Training Intervention, Schizophr Res; ePub 2018 Dec 21; Hansen, et al

Targeted Auditory Training in Schizophrenia Assessed, Int J Psychophysiol; ePub 2018 Dec 29; Roach, et al

Brain Anomalies in FDRs of Those with Schizophrenia, Schizophr Bull; ePub 2018 Dec 28; de Zwarte, et al

Auditory Deficits in Persons with Schizophrenia, Schizophr Res; ePub 2019 Jan 18; Medalia, et al

Negative Symptom Domains in Schizophrenia and BD, Schizophr Bull; ePub 2019 Jan 14; Strauss, et al

Must Reads in FDA Actions

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