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Navifus Corporation

FDA 510(k) & PMA Approved Devices — 1 products

Total Devices1
Categories1
Latest FDA decision2022-05-05
TypeNumberDevice NameCodeDateActions
510(k) K211529 NAVIRFA ScopeIYO2022-05-05 View

Related Clinical Trials

NCT04446416Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM PatientsCOMPLETEDNCT04988750Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM PatientsCOMPLETEDNCT06329570Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)RECRUITINGNCT06388707A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant EpilepsyRECRUITINGNCT06492720A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant EpilepsyRECRUITINGNCT06496971A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubble-mediated Focused Ultrasound (FUS-MB) Using NaviFUS System in Recurrent Glioblastoma Multiforme PatientsRECRUITINGNCT07274787Safety And Effectiveness Of NaviFUS System With Bevacizumab In Recurrent GlioblastomaNOT_YET_RECRUITING
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