The FDA today said it granted de novo approval for Brainsway‘s deep transcranial magnetic stimulation system, now indicated for treating obsessive compulsive disorder.
The TMS system uses magnetic fields to simulate nerves in the brain, and has been shown to reduce the severity of OCD in patients.
A 100-patient randomized, multi-center study of the device indicated that patients who received TMS treatment alongside medical management had a higher response rate, at 38%, than those treated with medical management and a sham device, at 11%.
The most frequent adverse reaction was headache, which was reported by 37.5% of patients who received treatment with the Brainsway device and 35.3% of patients who received sham treatment. No serious adverse reactions were reported and other adverse reactions, including application site pain or discomfort, jaw pain, facial pain, muscle pain, spasm or twitching and neck pain were reported as mild or moderate and resolved shortly after treatment, according to the FDA.
The newly cleared Brainsway device is contraindicated for patients with metallic objects or implanted stim devices in or near the head.
“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches. With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option,” FDA Center for Devices and Radiological Health Division of Neurological and Physical Medicine Devices director Carlos Peña said in a press release.
Last December, Brainsway reportedly raised $8.5 million.