Literature DB >> 23117769

Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval.

Connie E Chen1, Sanket S Dhruva, Rita F Redberg.   

Abstract

Mesh：

Year:  2012        PMID： 23117769     DOI： 10.1001/jama.2012.14491

Source DB:  PubMed          Journal:  JAMA        ISSN： 0098-7484            Impact factor:   56.272


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  10 in total

1.  How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Authors:  Andre M Samuel; Vinay K Rathi; Jonathan N Grauer; Joseph S Ross
Journal:  Clin Orthop Relat Res       Date:  2015-11-19       Impact factor: 4.176

Review 2.  Approval of high-risk medical devices in the US: implications for clinical cardiology.

Authors:  Benjamin N Rome; Daniel B Kramer; Aaron S Kesselheim
Journal:  Curr Cardiol Rep       Date:  2014       Impact factor: 2.931

3.  Medical device postapproval safety monitoring: where does the United States stand?

Authors:  Prashant V Rajan; Daniel B Kramer; Aaron S Kesselheim
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2015-01-06

4.  Improving medical device regulation: the United States and Europe in perspective.

Authors:  Corinna Sorenson; Michael Drummond
Journal:  Milbank Q       Date:  2014-03       Impact factor: 4.911

5.  FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

Authors:  Benjamin N Rome; Daniel B Kramer; Aaron S Kesselheim
Journal:  JAMA       Date:  2014 Jan 22-29       Impact factor: 56.272

6.  Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

Authors:  Sarah Y Zheng; Sanket S Dhruva; Rita F Redberg
Journal:  JAMA       Date:  2017-08-15       Impact factor: 56.272

7.  Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports.

Authors:  Lee Chang; Sanket S Dhruva; Janet Chu; Lisa A Bero; Rita F Redberg
Journal:  BMJ       Date:  2015-06-10

8.  Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

Authors:  Joseph S Ross; Katrina L Blount; Jessica D Ritchie; Beth Hodshon; Harlan M Krumholz
Journal:  Med Devices (Auckl)       Date:  2015-05-27

9.  Survival in Women Versus Men Following Implantation of Pacemakers, Defibrillators, and Cardiac Resynchronization Therapy Devices in a Large, Nationwide Cohort.

Authors:  Niraj Varma; Suneet Mittal; Julie B Prillinger; Jeff Snell; Nirav Dalal; Jonathan P Piccini
Journal:  J Am Heart Assoc       Date:  2017-05-10       Impact factor: 5.501

10.  Health care policy and regulatory implications on medical device innovations: a cardiac rhythm medical device industry perspective.

Authors:  Arjun Sharma; Anthony Blank; Parashar Patel; Kenneth Stein
Journal:  J Interv Card Electrophysiol       Date:  2013-03-10       Impact factor: 1.900
  10 in total

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