FDA Panel Recommends Approval of Neuropace's Anti-Epilepsy Implant
NeuroPace makes progress in its years-long road to FDA approval with near-unanimous approval for its RNS neurostimulation therapy for epileptic seizures.
California neurostimulation devices maker NeuroPace crept 1 step closer to an FDA win for its epilepsy implant with near-unanimous approval from the FDA's Neurological Devices Advisory Panel.
The expert panelists today voted unanimously that the RNS implantable neurostimulator demonstrated safety in clinical trials, 12 of 13 voted that the device demonstrated reasonable effectiveness, and 11 of 13 voted that the benefits outweigh the risks. There were no negative votes from the panel, with 1 member abstaining on the question of effectiveness and 2 abstaining from the question of the risk-benefit ratio.