Aleva Neurotherapeutics: Aleva granted FDA approval to study directSTIM in the U.S

The directSTIM DBS system is C.E. marked for sale in Europe as a treatment for Parkinson's disease and essential tremors. The company has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) study. This marks a major step in bringing the device to the U.S market.