Brainsway has received an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA), allowing it to begin a multi-center clinical trial to evaluate the efficacy of its Deep TMS device in the treatment of subjects with bipolar disorder. The IDE was granted in respect of nine medical centers and 120 patients.
The commencement of the trial is subject to receipt of Investigational Review Board approvals (the equivalent of Helsinki Committee approvals) from the participating sites, and to the recruitment of subjects.
The IDE granted to the company did not specify the regulatory pathway that would be required for approval of its Deep TMS therapy for bipolar disorder. However, based on the regulatory pathway of FDA approval for the company's depression therapy, as well as other considerations, the company estimates that the therapy will be approved via the 510(k) PreMarket Notification process.