FDA Approval and Labeling*

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm510521.htm

Elias WJ, Lipsman N, Ondo WG, Ghanouni P, Kim YG, Lee W, Schwartz M, Hynynen K, Lozano AM, Shah B, Huss D, Dallapiazza RF, Gwinn R, Witt J, Ro S, Eisenberg HM, Fishman PS, Gandhi D, Halpern CH, Chuang R, Butts Pauly K, Tierney TS, Hayes MT, Cosgrove GR, Yamaguchi T, Abe K, Taira T, Chang JW., An International, Randomized, Controlled Trial of Focused Ultrasound Thalamotomy for Essential Tremor. The New England Journal of Medicine, Aug 2016.

FDA labeling: Neuravive is intended for use in the unilateral Thalamotomy treatment of idiopathic Essential Tremor patients with medication-refractory tremor.