Literature DB >> 28742887

Practical Improvements for Medical Device Evaluation.

Daniel B Kramer1, Robert W Yeh1.   

Abstract

Entities:  

Year:  2017        PMID： 28742887      PMCID： PMC6150452          DOI： 10.1001/jama.2017.8976

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


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  13 in total

1.  Do postmarketing surveillance studies represent real-world populations? A comparison of patient characteristics and outcomes after carotid artery stenting.

Authors:  Robert W Yeh; Kevin Kennedy; John A Spertus; Sahil A Parikh; Rahul Sakhuja; H Vernon Anderson; Christopher J White; Kenneth Rosenfield
Journal:  Circulation       Date:  2011-03-21       Impact factor: 29.690

2.  Effectiveness of Arterial Closure Devices for Preventing Complications With Percutaneous Coronary Intervention: An Instrumental Variable Analysis.

Authors:  Neil J Wimmer; Eric A Secemsky; Laura Mauri; Matthew T Roe; Paramita Saha-Chaudhuri; David Dai; James M McCabe; Frederic S Resnic; Hitinder S Gurm; Robert W Yeh
Journal:  Circ Cardiovasc Interv       Date:  2016-04       Impact factor: 6.546

3.  Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.

Authors:  Ian S Reynolds; Joshua P Rising; Allan J Coukell; Kirsten H Paulson; Rita F Redberg
Journal:  JAMA Intern Med       Date:  2014-11       Impact factor: 21.873

4.  N-of-1 Policymaking--Tragedy, Trade-offs, and the Demise of Morcellation.

Authors:  Lisa Rosenbaum
Journal:  N Engl J Med       Date:  2016-03-10       Impact factor: 91.245

5.  Need for a National Evaluation System for Health Technology.

Authors:  Jeffrey Shuren; Robert M Califf
Journal:  JAMA       Date:  2016-09-20       Impact factor: 56.272

6.  Relationship Between Femoral Vascular Closure Devices and Short-Term Mortality From 271 845 Percutaneous Coronary Intervention Procedures Performed in the United Kingdom Between 2006 and 2011: A Propensity Score-Corrected Analysis From the British Cardiovascular Intervention Society.

Authors:  Vasim Farooq; Dick Goedhart; Peter Ludman; Mark A de Belder; Alun Harcombe; Magdi El-Omar
Journal:  Circ Cardiovasc Interv       Date:  2016-06       Impact factor: 6.546

7.  Registry-Based Prospective, Active Surveillance of Medical-Device Safety.

Authors:  Frederic S Resnic; Arjun Majithia; Danica Marinac-Dabic; Susan Robbins; Henry Ssemaganda; Kathleen Hewitt; Angelo Ponirakis; Nilsa Loyo-Berrios; Issam Moussa; Joseph Drozda; Sharon-Lise Normand; Michael E Matheny
Journal:  N Engl J Med       Date:  2017-01-25       Impact factor: 91.245

8.  User fees and beyond--the FDA Safety and Innovation Act of 2012.

Authors:  Daniel B Kramer; Aaron S Kesselheim
Journal:  N Engl J Med       Date:  2012-10-04       Impact factor: 91.245

9.  Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

Authors:  Vinay K Rathi; Harlan M Krumholz; Frederick A Masoudi; Joseph S Ross
Journal:  JAMA       Date:  2015-08-11       Impact factor: 56.272

10.  Postmarket surveillance of medical devices: a comparison of strategies in the US, EU, Japan, and China.

Authors:  Daniel B Kramer; Yongtian T Tan; Chiaki Sato; Aaron S Kesselheim
Journal:  PLoS Med       Date:  2013-09-24       Impact factor: 11.069
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  1 in total

1.  Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data.

Authors:  Sanket S Dhruva; Craig S Parzynski; Ginger M Gamble; Jeptha P Curtis; Nihar R Desai; Robert W Yeh; Frederick A Masoudi; Richard Kuntz; Richard E Shaw; Danica Marinac-Dabic; Art Sedrakyan; Sharon-Lise T Normand; Harlan M Krumholz; Joseph S Ross
Journal:  J Am Heart Assoc       Date:  2020-02-16       Impact factor: 5.501
  1 in total

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