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  • United States regulatory approval of medical devices used for endovascular neurosurgery: A two-decade review of FDA regulatory files

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Original research
United States regulatory approval of medical devices used for endovascular neurosurgery: A two-decade review of FDA regulatory files
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Authors

  • Lokeshwar S Bhenderu Department of Neurological Surgery, Houston Methodist Hospital, Houston, Texas, USA Clinical Innovations Laboratory, Houston Methodist Research Institute, Houston, Texas, USA Center for Translational Neural Prosthetics and Interfaces, Houston Methodist Research Institute, Houston, Texas, USA PubMed articlesGoogle scholar articles
  • Trevor Hardigan Department of Neurological Surgery, Icahn School of Medicine at Mount Sinai Hospital, New York, New York, USA PubMed articlesGoogle scholar articles
  • Jorge Roa Department of Neurological Surgery, Icahn School of Medicine at Mount Sinai Hospital, New York, New York, USA PubMed articlesGoogle scholar articles
  • Brandon D Philbrick Department of Neurological Surgery, Icahn School of Medicine at Mount Sinai Hospital, New York, New York, USA PubMed articlesGoogle scholar articles
  • Alex Hoang Department of Neurological Surgery, Houston Methodist Hospital, Houston, Texas, USA Center for Translational Neural Prosthetics and Interfaces, Houston Methodist Research Institute, Houston, Texas, USA PubMed articlesGoogle scholar articles
  • Amir H Faraji Department of Neurological Surgery, Houston Methodist Hospital, Houston, Texas, USA Clinical Innovations Laboratory, Houston Methodist Research Institute, Houston, Texas, USA Center for Translational Neural Prosthetics and Interfaces, Houston Methodist Research Institute, Houston, Texas, USA PubMed articlesGoogle scholar articles
  • Gavin W Britz Department of Neurological Surgery, Houston Methodist Hospital, Houston, Texas, USA Center for Translational Neural Prosthetics and Interfaces, Houston Methodist Research Institute, Houston, Texas, USA PubMed articlesGoogle scholar articles
  • Kurt A Yaeger Department of Neurological Surgery, Houston Methodist Hospital, Houston, Texas, USA Clinical Innovations Laboratory, Houston Methodist Research Institute, Houston, Texas, USA Center for Translational Neural Prosthetics and Interfaces, Houston Methodist Research Institute, Houston, Texas, USA PubMed articlesGoogle scholar articles
  1. Correspondence to Lokeshwar S Bhenderu; lokeshwar.bhenderu{at}gmail.com
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Citation

Bhenderu LS, Hardigan T, Roa J, et al
United States regulatory approval of medical devices used for endovascular neurosurgery: A two-decade review of FDA regulatory files
Journal of NeuroInterventional Surgery 2024;16:1216-1219.

Publication history

  • Received June 16, 2023
  • Accepted October 16, 2023
  • First published November 3, 2023.
Online issue publication 
November 22, 2024

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© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.