Transcranial magnetic stimulation (TMS) has been a promising new technology that’s been undergoing trials for such disparate conditions as depression, smoking cessation, ADD, Alzheimer’s, cocaine addiction, and multiple sclerosis. Now the FDA has issued approval to Brainsway, a leader in TMS based in Israel, to evaluate the device as a therapy option for people with bipolar disorder.
The Investigational Device Exemption (IDE) that was granted will lead to a study involving nine medical centers and 120 patients.
The IDE granted to the Company did not specify the regulatory pathway that would be required for approval of the Company’s 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.
Flashbacks: Brainsway’s Transcranial Magnetic Stimulation Gets European Regulatory Approval for Treatment of Depression; Brainsway to Test TMS for Smoking Cessation; VA to Trial Transcranial Magnetic Stimulation for ADD; Transcranial Magnetic Stimulation Shows Initial Promise in Alzheimer’s Trial; Magnetic Brain Stimulation for Cocaine Addiction, Multiple Sclerosis?;