Brainsway gets FDA approval to begin bipolar disorder trial
Brainsway has received investigational device exemption approval from the US Food and Drug Administration (FDA) to initiate a multicentre clinical trial to investigate the efficacy of its deep transcranial magnetic stimulation device as a treatment for bipolar disorder.
Brainsway has received investigational device exemption approval from the US Food and Drug Administration (FDA) to initiate a multicentre clinical trial to investigate the efficacy of its deep transcranial magnetic stimulation device as a treatment for bipolar disorder.
The device enables non-invasive depolarisation or hyperpolarisation of brain neurons.
The trial will involve on 120 patients at nine medical centres.