The US Food and Drug Administration, an agency within the US Department of Health and Human Services, reported on Friday that it has awarded approval for the marketing of the Brainsway Deep Transcranial Magnetic Stimulation System for treatment of obsessive compulsive disorder (OCD) through the de novo premarket review pathway.

This marketing approval has been awarded to health technology company Brainsway Ltd that provides brain disorder treatments.

OCD is a common, chronic and long-lasting disorder in which a person has uncontrollable, reoccurring thoughts and behaviours that a person feels the urge to repeat over and over. OCD is typically treated with medication, psychotherapy or a combination of the two.

According to the company,the Transcranial magnetic stimulation (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.

Additionally, the US FDA has reviewed data from a randomised, multi-centre study of 100 patients, of which 49 patients received treatment with the Brainsway device and 51 received treatment with a non-working (sham) device. The patients receiving OCD treatments (medical management) were maintained at their current dosages.

This TMS study evaluated the reduction in patients' Yale-Brown Obsessive Compulsive Scale (YBOCS) score, a common metric for measuring the severity of a patient's OCD. About 38% of patients responded to the Brainsway device, whereas 11% of patients responded when using the sham device, concluded the US FDA.

The agency protects public health in the US by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices. It is also is responsible for the safety and security of food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.