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# Transcranial Magnetic Stimulation Cleared for Anxiety
- URL: https://www.fdaweb.com/transcranial-magnetic-stimulation-cleared-for-anxiety/
- Published: 2022-07-20T12:00:00.000Z
- Updated: 2026-09-14T17:52:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152327

FDA has cleared a Neuronetics 510(k) for a new indication for its NeuroStar Advanced Therapy for Mental Health device, a transcranial magnetic stimulation system, for treating anxiety symptoms for adult patients who suffer from major depressive disorder, also known as anxious depression. The company says the clearance relied on Neuronetics’ use of real-world data analyzed from NeuroStar’s proprietary TrakStar platform, a database containing digital data from patients treated with NeuroStar at over 1,000 centers. “Real-world data from TrakStar is particularly valuable because it provides a large sample from a diverse patient group being treated in a clinical practice setting,” it says.

The TrakStar data from 664 patients demonstrated that 65.5% achieved a clinically meaningful response that exceeded the pre-established overall study success criteria of a minimum 50% response rate, according to Neuronetics.

In May, the device was cleared for an [obsessive compulsive disorder indication](https://www.globenewswire.com/Tracker?data=6Wf-x3f2M8Dk9wxy2Xr4r8Pjmwlrd0Cif3ewBvenDMuNTafSnk51HJei%5FCpptkNSYZOZQlgbdD1ZeVokxyLh65FZMzQ8eYOH4XI3td7Z4a4BW5zrqoQyBEGM%5FiTqLMg64aTedbX--bmmyNRZLRByW-vaXPEkWoOBUQi6KujGDLVldrQ-Wj1KWO73G9kuJ9Ys2TYjScz2IP4mxdDIcupZbrPXJmgesursfSaAobi7-FB7ZhZi8BBuq5jgX34IgwchADb8A38FXTQvD4AcL576U%5FABP9kq2UqklcVgZHgsbdsjTZ3hRW455S%5FWbXmLar-ATL1yQs9nF84QEnnnOA9UBw==&ref=fdaweb.com).