StoryRegulatory
FDA grants Breakthrough Device Designation to RNS System for idiopathic generalized epilepsy
The FDA's Breakthrough Device Program recognized the RNS System's potential for treating drug-resistant idiopathic generalized epilepsy, which affects up to one-third of epilepsy patients. The designation expedites development and review of therapies that provide breakthrough innovations for life-threatening or irreversibly debilitating conditions.
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