SOZO Brain Center is proud to announce a major regulatory milestone: the Newronika HDCkit transcranial direct current stimulation (tDCS) device has officially received Therapeutic Goods Administration (TGA) approval in Australia. This certification marks a pivotal moment in expanding access to safe, non-invasive, and scientifically backed neuromodulation treatments across the region.
SOZO will soon visit Australia to train doctors on Neuromodulation Techniques Protocols and Devices during our well-established Neuromodulation Techniques Workshops. Doctors who participate in our 2-day hands-on workshops, learn how to use advanced neuromodulation techniques based on scientifically validated protocols during live patient demonstrations.
If you are interested in attending our Neuromodulation Techniques Workshop in Sydney (31 October-1 November 2025) click here.
Approved Uses of the HDCkit System
The Newronika HDCkit System, now approved for use in Australia, is indicated for supporting treatment of the following conditions:
- Chronic Pain
- Post-Stroke Rehabilitation
- Depression
Each application is based on decades of cumulative research and growing clinical evidence. The system provides neuromodulation treatments that are safe, drug-free, and customizable to individual patient needs. Importantly, the system must be operated under the supervision of trained medical professionals to ensure optimal results and patient safety.
A Major Step Forward for SOZO and Neuromodulation in Australia
This TGA approval is more than a regulatory success — it represents SOZO Brain Center’s deep commitment to making cutting-edge, non-invasive treatments available to patients worldwide. With this approval, SOZO will now begin offering tDCS treatments using the HDCStim device across its Australian network and collaborating with local physicians to expand access through training, clinical partnerships, and certified treatment centers.
What Is tDCS and How Does It Work?
tDCS (transcranial direct current stimulation) is a non-invasive brain stimulation technique that modulates the excitability of targeted brain regions through the controlled delivery of low-intensity electrical currents. The method works by polarizing neurons—either increasing or decreasing their activity—depending on the placement of electrodes.
Over the last decade, tDCS has become widely used in clinical and research settings due to its safety profile and therapeutic benefits. When applied by trained professionals using regulated systems like the HDCkit, this approach offers meaningful relief and functional improvement in a range of neurological and neuropsychiatric conditions.
What’s Next?
The field of neuromodulation continues to evolve, with ongoing studies expanding the list of therapeutic indications for neuromodulation techniques.
We’re excited to bring this breakthrough to Australia and empower both patients and healthcare professionals with next-generation neurological care.
