TGA approves Sooma’s at-home brain stimulation for depression in Australia
Sooma Medical, a leader in non-invasive neuromodulation therapies, is pleased to announce that its next-generation transcranial Direct Current Stimulation (tDCS) system has received approval from the Therapeutic Goods Administration (TGA) for clinical use in Australia. The system is now included in the Australian Register of Therapeutic Goods (ARTG), enabling full commercial availability across the Australian healthcare sector.
This new approval builds on Sooma’s nearly decade-long presence in the country. The company’s earlier-generation tDCS system gained TGA approval in 2016 and has been used by clinicians across Australia in the treatment of major depressive disorder.
The next-generation Sooma tDCS device introduces a streamlined patient interface, integrated clinical protocols, and a remote digital monitoring platform. It is designed for patients to easily self-administer treatment in the comfort of their homes, with clinicians able to adjust treatment protocols, track patient progress, and review efficacy remotely. This model enhances treatment adherence and empowers more efficient care delivery to reduce burdens on health systems while expanding treatment access. This is particularly beneficial for individuals in rural or remote areas, where access to mental health care may be limited.
Sooma CEO Tuomas Neuvonen commented:
“TGA approval of our next-generation device is a major milestone for Sooma and a strong validation of our commitment to safe, effective neuromodulation. Having served clinicians and patients in Australia since 2016, we’re excited to introduce our most advanced system to date. By enabling home-based care with full clinical oversight, we’re helping clinicians reach more patients, more efficiently—regardless of location.”
With regulatory clearance secured, Sooma will expand its Australian commercial activities through clinical partnerships, distributor collaborations, and healthcare network engagement. Initial focus areas include mental health services and telehealth-supported care providers.
Sooma distributor:
Sonoray Pty Ltd
Unit 14, 12A Loyalty Road
NORTH ROCKS
NSW AUSTRALIA 2151
https://www.sonoray.com/
About Sooma Medical
Founded in 2013, Sooma Medical is a Finnish medical device company specializing in non-invasive brain stimulation devices for neurological and psychiatric disorders. Sooma works closely with leading medical experts to develop effective treatment solutions. Manufactured in Finland, Sooma’s devices adhere to strict ISO 13485 and MDSAP quality management standards. To date, more than 25,000 patients have found relief with these treatments. Sooma Depression Therapy is available in more than 35 countries worldwide. In September 2023, Sooma became the first tDCS device manufacturer to receive EU MDR certification for medical devices. In March 2023, Sooma received FDA Breakthrough Device Designation, reserved for novel therapies that show significant potential to provide a substantial improvement over existing options for severe or life-threatening conditions.
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