News & Press
European Medicines Agency fast-tracks review of INBRAIN graphene DBS for Parkinson's
EMA Official4/22/2026ยท04/22/26๐ Europe
Summary
The EMA has granted PRIME designation to INBRAIN Neuroelectronics' graphene-based DBS system for Parkinson's disease, enabling accelerated regulatory dialogue and potential priority review. PRIME designation, equivalent to FDA Breakthrough Device, is the first awarded to a graphene neural interface and only the third for any DBS technology.
Why it matters
EMA PRIME designation gives INBRAIN a direct scientific dialogue channel with regulators, typically cutting 12-18 months from review timelines. Combined with their ongoing first-in-human trial, INBRAIN is on a credible path to CE mark within 4 years.
#BCI#Deep Brain Stimulation#Europe#Neural Interfaces#Parkinson's
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