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Home » Soterix wins IDE for depression treatment trial

Soterix wins IDE for depression treatment trial

July 7, 2020 By Sean Whooley

Soterix MedicalSoterix Medical announced today that it received FDA investigational device exemption (IDE) to launch a trial of its tDCS-LTE) neuromodulation system.

New York-based Soterix Medical’s transcranial direct current stimulation-limited total energy (tDCS-LTE) system is an at-home platform for people suffering from major depressive disorder (MDD).

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.”

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Neurological, Neuromodulation/Neurostimulation, Regulatory/Compliance Tagged With: FDA, Soterix Medical

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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