Neuromodulation Device for Depression Granted Breakthrough Device Designation

vrx123/AdobeStock

Sooma Medical’s portable, patient-administered, noninvasive neuromodulation device to treat depression has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA).¹ The headset works via transcranial direct current stimulation, using a mild electrical current to stimulate targeted brain areas and significantly improve depressive symptoms.

“We are thrilled to receive this breakthrough designation from the FDA," said Sooma CEO Tuomas Neuvonen. “This is a huge step forward for our company and, more importantly, for the millions of people suffering from depression. We are committed to making this innovative treatment accessible to patients in the US as quickly as possible.”

Treatment sessions last 30 minutes, and the electrodes automatically shut off after completion. Sessions are designed to take place 5 days a week for 3 weeks, after which clinicians can assess their patients’ progress and determine how to continue.²

A recent study found that after approximately 16 sessions with this neuromodulation device, more than half of the study participants reported at least a 50% depressive symptom reduction. Additionally, 19.5% of participants achieved remission.³

“This study provides the largest real-world dataset hitherto reported on the efficiency and tolerability of tDCS in the treatment of MDD in real-world clinical practice,” said study authors.³

References

1. Sooma Medical receives FDA breakthrough device designation for its innovative at-home depression treatment device. Sooma Medical. News release. March 6, 2023. Accessed March 9, 2023. https://www.prnewswire.com/news-releases/sooma-medical-receives-fda-breakthrough-device-designation-for-its-innovative-at-home-depression-treatment-device-301762192.html

2. Park A. Sooma Medical's neurostim device for at-home depression treatment lands FDA breakthrough tag. MedTech. March 6, 2023. Accessed March 9, 2023. https://www.fiercebiotech.com/medtech/sooma-medicals-neurostim-device-home-depression-treatment-lands-fda-breakthrough-tag

3. Lõokene M, Markov N, Nikander M, et al. Reduction of symptoms in patients with major depressive disorder after transcranial direct current stimulation treatment: a real-world study. J Affect Disord. 2022;8:100347.