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Sooma Medical Gains FDA Approval for U.S. Trial of Depression Treatment
Sooma Medical has received FDA Investigational Device Exemption (IDE) approval to conduct a pivotal study on Sooma 2GEN, a wearable transcranial direct current stimulation (tDCS) device for Major Depressive Disorder (MDD). This non-invasive device delivers low-level electrical stimulation to the brain, offering a drug-free home treatment for depression.
The trial, in collaboration with Lindus Health, will involve 200 U.S. participants. Lindus Health will manage recruitment and operations through its Citrus eClinical platform.
Already approved in 35 countries, Sooma 2GEN holds an FDA Breakthrough Device Designation. Positive trial outcomes could support its U.S. market entry, reinforcing its safety and effectiveness.
This technology aims to provide an accessible, flexible alternative to traditional depression treatments, potentially expanding options for individuals seeking non-pharmaceutical therapies.
12-03-2025