According to published reports, The US Food and Drug Administration (FDA) has granted Breakthrough Device designation to Sooma Medical’s portable, noninvasive neuromodulation device for treating depression, which can be administered by the patient. The device, which uses transcranial direct current stimulation to target specific areas of the brain and alleviate depressive symptoms, has a treatment duration of 30 minutes per session, with electrodes that automatically turn off after completion. The treatment regimen involves sessions five days a week for three weeks, after which the clinician can evaluate the patient’s progress and decide on further steps. Sooma CEO Tuomas Neuvonen expressed enthusiasm about the designation and the opportunity to make the device accessible to US patients. Clinical studies have shown that after approximately 16 sessions, more than half of participants reported at least a 50% reduction in depressive symptoms, while 19.5% achieved remission. The study’s authors noted that this is the most extensive real-world data on the efficacy and tolerability of transcranial direct current stimulation for the treatment of Major Depressive Disorder.
From Psychiatric Times