BrainsWay's Deep TMS device is an FDA-cleared, non-invasive neurostimulation treatment. It uses a cushioned helmet equipped with patented H-coils designed to stimulate deeper and broader brain areas than traditional TMS.

• The device has been FDA cleared for multiple indications:

  • Major Depressive Disorder (MDD) since 2013,

  • Obsessive-Compulsive Disorder (OCD) since 2018,

  • Short-term smoking cessation aid since 2020,

  • Anxious Depression since 2021.

• It has been used in over 60 clinical trials worldwide, demonstrating safety and efficacy, with a well-tolerated side effect profile including minimal discomfort and some muscle twitching.

• The treatment involves electromagnetic fields produced by the helmet's coils to modulate neural activity in targeted brain areas, leading to a gradual reduction in symptom severity and improved quality of life, consistent with your description.

• BrainsWay's Deep TMS system has also received expanded FDA indications, including for patients aged 22 to 86 years in MDD treatment, highlighting ongoing clinical validation and regulatory approval.