The FDA cleared an expanded indication for Neuronetics' NeuroStar transcranial magnetic stimulation device to include adults with major depressive disorder and comorbid anxiety symptoms — sometimes called "anxious depression." It is the first device-specific clearance for this subtype, which represents an estimated 50-70% of all major depressive disorder cases.
The clearance was based on a 290-patient sham-controlled trial in which both depression and anxiety symptoms improved significantly with active TMS compared with sham. Anxiety has historically been associated with worse outcomes in pharmacological treatments for depression, making the device-specific data clinically relevant.
Treatment protocols and reimbursement are unchanged; the clearance primarily affects labeling and clinic marketing. Insurance coverage for TMS in major depressive disorder typically does not differentiate by anxiety status, so the immediate practical impact for patients is modest.
Neuronetics indicated the clearance also supports broader provider education on selecting TMS for patients whose depression has historically been difficult to treat with anxiolytic-resistant pharmacology.
Source
Reporting based on coverage from FDA Newsroom. This article is editorial summary intended for general information; it is not medical advice.