Early Feasibility Studies for Cardiovascular Devices in the United States-Reference-Cited by-同舟云学术

Early Feasibility Studies for Cardiovascular Devices in the United States

Published:2020-12 Issue:23 Volume:76 Page:2786-2794
ISSN:0735-1097
Container-title:Journal of the American College of Cardiology
language:en
Short-container-title:Journal of the American College of Cardiology

Author:

Holmes David R.,Farb Andrew A.,“Chip” Hance Robert,Leon Martin B.,Goldberg Pamela,Zuckerman Bram D.,Kaplan Aaron V.,Rincon-Gonzalez Liliana,Hunt Jon,Walkowiak Jaime,Mack Michael J.

Publisher

Elsevier BV

Subject

Cardiology and Cardiovascular Medicine

Reference9 articles.

1. 21st Century Cures Act of 2016. 114th Congress. Public Law 117-255. 130 Stat. 1033 (2016).

2. Overcoming the challenges of conducting early feasibility studies of medical devices in the United States;Holmes;J Am Coll Cardiol,2016

3. The 21st Century Cures Act and early feasibility studies for cardiovascular devices: what have we learned, where do we need to go?;Holmes;J Am Coll Cardiol Intv,2018

4. The Medical Device Innovation Consortium and its goal to further the efficiency of early feasibility studies in the United States;Holmes;Journal Endovasc Ther,2019

5. Clinical perspective—early feasibility device medical studies in the United States: time for more than regulatory reform;Holmes;J Am Coll Cardiol Intv,2016

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2. From bench to bedside: A narrative review and institutional experience with experimental models for vascular device design and translation;Seminars in Vascular Surgery;2022-12

3. Regulatory strategies for early device development and approval;Catheterization and Cardiovascular Interventions;2022-04-29

4. Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts;Journal of Cardiovascular Translational Research;2022-03-14

5. 2020 and Beyond: The Future Catheterization Laboratory;The Mayo Clinic Cardiac Catheterization Laboratory;2021