Does FDA-clearance of the TMS therapy system mean that all TMS devices are cleared for use in major depression within the United States?
No, the TMS therapy system is the first and only TMS device to be cleared by the U.S. Food and Drug Administration (FDA) for the treatment of major depression. The TMS therapy system is also the first and only TMS device to have been evaluated in a large, multicenter, controlled clinical trial. No other TMS device can claim to be “FDA-cleared” for the treatment of depression. These devices have not been proven to be safe and effective for treating depression.
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