Neuroelectrics’ Epilepsy Device Gets FDA Breakthrough Device Designation

Brain stimulation therapy company Neuroelectrics has received the FDA’s Breakthrough Device designation for its Starstim neuromodulation platform used for treatment of drug-resistant epilepsy.

The Starstim device, which does not require a hospital setting, combines transcranial electrical stimulation with personalized treatment protocols and cloud-based software.

The company recently completed a pilot study of its system in 20 adult and pediatric patients with drug-resistant epilepsy in which the patients experienced a 44 percent reduction in seizure frequency in the eight weeks post-treatment.