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European Approval For BioControl Medical’s Nerve Stimulation System For Treatment-Resistant Depression

BioControl Medical’s FitNeS vagus nerve stimulation system now has a second approved European indication: treatment-resistant depression. This follows the implantable neuromodulation system’s first CE mark for drug-resistant epilepsy in 2010.

The FitNeS vagus nerve stimulation system from Israel-based BioControl Medical Ltd. now has a second approved European indication: treatment-resistant depression (TRD). This follows the implantable neuromodulation system’s first CE mark for drug-resistant epilepsy (DRE) in 2010. Sister company [CerebralRx Ltd.] is commercializing the product for both indications.

TRD is classified as a major depressive disorder that has not responded to four or more classes of antidepressant drugs....

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