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Neuronetics Gets US FDA Clearance for Treatment of Adolescents with Depression; Shares Rise
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Neuronetics Gets US FDA Clearance for Treatment of Adolescents with Depression; Shares Rise
Mar 25, 2024 7:31 AM

10:14 AM EDT, 03/25/2024 (MT Newswires) -- Neuronetics ( STIM ) said Monday the US Food and Drug Administration approved its NeuroStar Advanced Therapy as an adjunct to treat depression in adolescents aged 15 to 21.

This is the fourth indication the FDA has approved for NeuroStar, a transcranial magnetic stimulation treatment, the company said.

The FDA's decision to clear the new indication was based partly on the analysis of data gathered via NeuroStar's TrakStar platform, according to a statement.

The regulator "reviewed the comprehensive data set from TrakStar, along with clinical data from the published literature, and concluded that NeuroStar TMS was substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy over antidepressant therapy alone in this population," the company said.

Neuronetics ( STIM ) shares rose 12% in recent trading Monday.

Price: 4.75, Change: +0.52, Percent Change: +12.29

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