Literature DB >> 21830961

Medical devices and health--creating a new regulatory framework for moderate-risk devices.

David R Challoner1, William W Vodra.   

Abstract

Mesh：

Year:  2011        PMID： 21830961     DOI： 10.1056/NEJMp1109150

Source DB:  PubMed          Journal:  N Engl J Med        ISSN： 0028-4793            Impact factor:   91.245


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  14 in total

1.  While we wait for a new regulatory framework for surgical mesh.

Authors:  Gunnar Lose; Søren Gräs
Journal:  Int Urogynecol J       Date:  2012-08       Impact factor: 2.894

2.  Regulatory review of novel therapeutics--comparison of three regulatory agencies.

Authors:  Nicholas S Downing; Jenerius A Aminawung; Nilay D Shah; Joel B Braunstein; Harlan M Krumholz; Joseph S Ross
Journal:  N Engl J Med       Date:  2012-05-16       Impact factor: 91.245

3.  Editorial Commentary: Hard questions for mobile technology in cardiology.

Authors:  Daniel B Kramer; Robert W Yeh; Peter J Zimetbaum
Journal:  Trends Cardiovasc Med       Date:  2016-02-01       Impact factor: 6.677

4.  FDA regulation of cardiovascular devices and opportunities for improvement.

Authors:  Sanket S Dhruva; Rita F Redberg
Journal:  J Interv Card Electrophysiol       Date:  2012-12-21       Impact factor: 1.900

5.  Reply to the commentary by Dr. Sauerland S. and Dr. Gross CTR.

Authors:  Gianlorenzo Dionigi; Markus W Büchler; Martin Schneider; Stefan Sauerland; Christian T R Gross
Journal:  Langenbecks Arch Surg       Date:  2012-10-13       Impact factor: 3.445

6.  Trends in the use of percutaneous ventricular assist devices: analysis of national inpatient sample data, 2007 through 2012.

Authors:  Rohan Khera; Peter Cram; Xin Lu; Ankur Vyas; Alicia Gerke; Gary E Rosenthal; Phillip A Horwitz; Saket Girotra
Journal:  JAMA Intern Med       Date:  2015-06       Impact factor: 21.873

7.  N,N-dimethyl-p-toluidine, a component in dental materials, causes hematologic toxic and carcinogenic responses in rodent model systems.

Authors:  June K Dunnick; A Brix; J M Sanders; G S Travlos
Journal:  Toxicol Pathol       Date:  2013-07-18       Impact factor: 1.902

Review 8.  How does medical device regulation perform in the United States and the European union? A systematic review.

Authors:  Daniel B Kramer; Shuai Xu; Aaron S Kesselheim
Journal:  PLoS Med       Date:  2012-07-31       Impact factor: 11.069

9.  Placing a price on medical device innovation: the example of total knee arthroplasty.

Authors:  Lisa G Suter; A David Paltiel; Benjamin N Rome; Daniel H Solomon; Thomas S Thornhill; Stanley K Abrams; Jeffrey N Katz; Elena Losina
Journal:  PLoS One       Date:  2013-05-06       Impact factor: 3.240

10.  Modified classification of surgical meshes for hernia repair based on the analyses of 1,000 explanted meshes.

Authors:  U Klinge; B Klosterhalfen
Journal:  Hernia       Date:  2012-05-05       Impact factor: 4.739
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