Phase 3 trial launched for depression treatment device

Lindus Health and Sooma Medical have launched a phase 3 clinical trial to test the effectiveness of the Sooma 2GEN device for treating major depressive disorder (MDD). This follows FDA approval for an investigational device exemption on March 11, 2025. The trial will involve about 200 participants across the U.S. and aims to assess the safety and efficacy of the home-based transcranial direct current stimulation (tDCS) treatment. Previous studies indicated significant improvement in depressive symptoms among patients using the device. Sooma 2GEN has already been approved for MDD treatment in several European countries. This trial could pave the way for its market entry in the U.S. if results are positive.