FDA Greenlights Soterix Medical Depression tDCS-LTE Therapy IDE

Perhaps no medical application of transcranial Direct Current Stimulation (tDCS) has received more interest than the treatment of depression, especially as a therapy for patients for whom drugs and other therapies don’t work.

The FDA has awarded Soterix Medical an investigational device exemption (IDE) for its tDCS-LTE depression therapy. An IDE is a key step toward the FDA approval of a therapy.

In the press release, Mr. Rodriguez, Soterix Medical’s VP of Regulatory Affairs, says “The tDCS-LTE therapy is approved for the treatment of Major Depression across the globe including Europe, Australia, Brazil, etc.”  This is an important point in that Soterix Medical tDCS therapy is already approved over much of the world, while remaining an off-label therapy in the US. The tDCS-LTE trial should remedy that. 

The fact 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.  Dr. Datta, CTO of Soterix Medical says, “The home-based tDCS-LTE therapy…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.”  The mini-CT system is the Soterix Medical home-based device that only works under clinical or research supervision through the ElectraRx software.


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