Device Dossier

Transcranial magnetic stimulation system, mobile

Device Dossier for Transcranial magnetic stimulation system, mobile (Transcranial magnetic stimulation system, mobile, Class IIa, sponsor BTL Medical…

Intended purpose

The device is intended for repetitive transcranial magnetic stimulation (rTMS). The device is intended for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication, at or above the minimal effective dose and duration in the current episode, reduction the symptoms of comorbid anxiety in patients suffering from MDD, as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD) and treatment of Binge Eating Disorder (BED).

TGA Public Summary