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FDA Clears NeuroStar Indication for Anxiety Symptoms in Depression (2022)

In July 2022 the FDA cleared an expanded NeuroStar indication covering anxiety symptoms in adults with major depressive disorder ("anxious depression"), based on real-world data from Neuronetics' TrakStar platform.

FDA Approvals July 19, 2022 · MassDevice ↗

In July 2022, the FDA cleared an expanded indication for Neuronetics' NeuroStar transcranial magnetic stimulation system covering the treatment of depressive episodes and decreasing anxiety symptoms in adults with major depressive disorder (MDD) who may have comorbid anxiety symptoms, sometimes called "anxious depression." The patients covered are those who did not achieve satisfactory improvement from antidepressant medication in the current episode.

Neuronetics said the FDA accepted real-world data analyzed from its TrakStar outcomes platform as the basis for the clearance. The system was previously FDA-cleared for treatment-resistant depression and obsessive-compulsive disorder.

This is an older item retained for context. Check with a clinic about which indications apply to the specific device it uses.

Source

Reporting based on coverage from MassDevice. This article is editorial summary intended for general information; it is not medical advice.

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