OCD Indication Approved For Brainsway TMS Device
US FDA used its de novo review pathway to approve Brainsway Ltd.’s Brainsway Deep Transcranial Magnetic Stimulation System to treat obsessive compulsive disorder.
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A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, two Health Canada approvals, and more.
The Helsinki-based company had expected stroke rehabilitation to be the first FDA-cleared indication for its Navigated Brain Therapy system, but while more data is collected for that program, it is pursuing a 510(k) clearance for NBS to treat major depressive disorder and plans to build a US salesforce to market NBS for therapeutic indications.
The US FDA has granted 510(k) clearance for the first transcranial magnetic stimulation (TMS) device for depression, Neuronetics' Neurostar. The specific indication is for the treatment of adults with major depressive disorder who have not responded to antidepressant drugs.