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RNS® System

187 bytes added, 10:12, 1 December 2016
public policy
== Public Policy ==
The RNS System was approved by Food and Drug Administration (FDA) in 2013 based on clinical studies. Those contain a Feasibility study, a Pivotal study, and a Long-term Treatment study. There were also several studies in laboratory, where were tested every single device of the RNS System. Before human studies, there were also studies on animals, particularly on sheep.<ref name="SSFD">Summary of Safety and Effectiveness Data (SSED). U.S. Food & Drug Administration [online]. 2013. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100026B.pdf (Retrieved 4.11.2016)</ref>
The RNS System devices are connected with several patents. On the website of the NeuroPace company, there are list of the patents for every single device of RNS System: NeuroPace® RNS® Neurostimulator, NeuroPace® Depth Lead, NeuroPace® Cortical Strip Lead, NeuroPace® Programmer, NeuroPace® Remote Monitor, Wand and Ferrule.<ref name="NeuroPace_patents">NeuroPace. Legal Terms. NeuroPace, Inc. [online]. © 2016. Available online at: http://www.neuropace.com/legal/ (Retrieved 30.11.2016)</ref>
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