Literature DB >> 27398696

Need for a National Evaluation System for Health Technology.

Jeffrey Shuren1, Robert M Califf1.   

Abstract

Mesh：

Year:  2016        PMID： 27398696     DOI： 10.1001/jama.2016.8708

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


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  28 in total

1.  How much clinical evidence is enough: regulation of medical devices?

Authors:  Jonathan P Jarow; Charles Viviano; John H Baxley
Journal:  Ann Transl Med       Date:  2016-10

2.  Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration.

Authors:  Joseph P Drozda; James Roach; Thomas Forsyth; Paul Helmering; Benjamin Dummitt; James E Tcheng
Journal:  J Am Med Inform Assoc       Date:  2018-02-01       Impact factor: 4.497

3.  Transparency and Dermatologic Device Approval by the US Food and Drug Administration.

Authors:  Harib H Ezaldein; Jeffrey F Scott; Emily S Yin; Alessandra Ventura; Nicholaas P DeRuyter; David J Leffell
Journal:  JAMA Dermatol       Date:  2018-03-01       Impact factor: 10.282

4.  Incentivizing research into the effectiveness of medical devices.

Authors:  Michael Drummond; Rosanna Tarricone; Aleksandra Torbica
Journal:  Eur J Health Econ       Date:  2016-12

5.  Achieving Data Liquidity: Lessons Learned from Analysis of 38 Clinical Registries (The Duke-Pew Data Interoperability Project.

Authors:  James E Tcheng; Joseph P Drozda; Davera Gabriel; Anne Heath; Rebecca W Wilgus; Mary Williams; Thomas A Windle; John R Windle
Journal:  AMIA Annu Symp Proc       Date:  2020-03-04

6.  Validation of Administrative Claims to Ascertain Outcomes in Pivotal Trials of Transcatheter Aortic Valve Replacement.

Authors:  Neel M Butala; Jordan B Strom; Kamil F Faridi; Dhruv S Kazi; Yuansong Zhao; J Matthew Brennan; Jeffrey J Popma; Changyu Shen; Robert W Yeh
Journal:  JACC Cardiovasc Interv       Date:  2020-07-15       Impact factor: 11.195

7.  Diabetes digital app technology: benefits, challenges, and recommendations. A consensus report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group.

Authors:  G Alexander Fleming; John R Petrie; Richard M Bergenstal; Reinhard W Holl; Anne L Peters; Lutz Heinemann
Journal:  Diabetologia       Date:  2020-02       Impact factor: 10.122

Review 8.  Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative.

Authors:  J Stephen Mikita; Jules Mitchel; Nicolle M Gatto; John Laschinger; James E Tcheng; Emily P Zeitler; Arlene S Swern; E Dawn Flick; Christopher Dowd; Theodore Lystig; Sara B Calvert
Journal:  Ther Innov Regul Sci       Date:  2020-06-22       Impact factor: 1.778

9.  Practical Improvements for Medical Device Evaluation.

Authors:  Daniel B Kramer; Robert W Yeh
Journal:  JAMA       Date:  2017-07-25       Impact factor: 56.272

10.  Active Surveillance of the Implantable Cardioverter-Defibrillator Registry for Defibrillator Lead Failures.

Authors:  Frederic S Resnic; Arjun Majithia; Sanket S Dhruva; Henry Ssemaganda; Susan Robbins; Danica Marinac-Dabic; Kathleen Hewitt; Lucila Ohno-Machado; Matthew R Reynolds; Michael E Matheny
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2020-04-14
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