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Soterix Gains Approval for Trial of Device to Treat Major Depressive Disorder

The New York-based company said there is a strong need for its Direct Current Stimulation-Limited Total Energy (tDCS-LTE) neuromodulation at-home for patients because of COVID-19.

FDA has greenlit Soterix Medical’s bid to launch a trial for the home-based transcranial Direct Current Stimulation (tDCS) to treat Major Depressive Disorder (MDD).

The New York-based company said it developed proprietary technology supporting reliable home-based transcranial Direct Current Stimulation (tDCS) including the single-use SNAPpad electrodes that ensure clean and tolerated therapy at-home, and the ElectraRx digital healthcare platform that provides caregivers ongoing insight on patient response and full control of ongoing therapy.

Soterix said COVID-19 pandemic has made it evident that the need is urgent for home-based therapies focused on suffering from MDD.

In a release, Dr. Abhishek Datta, Soterix’s CTO said, “The home-based tDCS-LTE therapy continues our commitment to lead in the creation of innovative non-invasive neuromodulation treatments. 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. That Soterix Medical pioneered home-based tDCS research with by far the most extensive track record on successful use was a factor in the FDA's decision to approve the trial.”

TAGS: Technologies
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