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BioWorld - Friday, February 13, 2026
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Home » Neuromodulation for MDD heads home
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Neuromodulation for MDD heads home

Jan. 12, 2026
By Annette Boyle
For individuals with major depressive disorder (MDD) that does not respond to pharmacotherapy, recent decisions by the U.S. FDA enabling at-home use of neuromodulation devices may provide a bright spot in dark days. Neurolief Ltd. received FDA premarket approval for Proliv Rx, a physician-directed, brain neuromodulation therapy indicated for use as an at-home adjunctive treatment for adults with MDD who failed to respond adequately to at least one previous antidepressant on Jan. 7. That decision follows the December 510(k) clearance for at-home use of the Flow brain-stimulation device by Flow Neuroscience AB as either a monotherapy or as an adjunctive treatment.
Medical technology Regulatory Neurology/psychiatric U.S. FDA

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