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FDA Reclassifies Electroconvulsive Therapy Devices To Lower Risk Class For Some Uses

News | February 4, 2019

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On December 26, 2018, the U.S. Food and Drug Administration (FDA) issued a final order to reclassify electroconvulsive therapy (ECT) devices to a lower-risk level. The new classification applies only when the device is used for ECT to treat catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar…

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