Soterix Medical has announced that it received US Food and Drug Administration (FDA) investigational device exemption (IDE) to launch a trial of its non-invasive transcranial direct current simulation-limited total energy (tDCS-LTE) neuromodulation system. The system is an at-home platform intended for those suffering from major depressive disorder (MDD).
According to a company press release, the proprietary technology is designed to support the home-based tDCS, including the single-use SNAPpad electrodes and the ElextraRx digital healthcare platform, according to a news release.
Amid the COVID-19 pandemic, Soterix says there is an even more urgent need for reliable at-home intervention for patients with MDD. With the IDE trial, it’s setting out to benefit those patients whose access to depression therapy has been limited as a result of the pandemic.
“The home-based tDCS-LTE therapy continues our commitment to lead in the creation of innovative non-invasive neuromodulation treatments,” Soterix chief technology officer Abhishek Datta said in the release. “Reliable home-use requires several unique technologies including our breakthrough mini-CT stimulator and SNAP accessories, proprietary LTE current management, and the simple and powerful ElectraRx portal.”