Literature DB >> 22332952

Regulation of medical devices in the United States and European Union.

Daniel B Kramer1, Shuai Xu, Aaron S Kesselheim.   

Abstract

Mesh：

Year:  2012        PMID： 22332952     DOI： 10.1056/NEJMhle1113918

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


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  48 in total

1.  The potential for PCR based testing to improve diagnosis and treatment of sepsis.

Authors:  Ngan Lyle; John Boyd
Journal:  Curr Infect Dis Rep       Date:  2013-10       Impact factor: 3.725

2.  An exploration of nursing home residents' experiences of a non-powered static air mattress overlay to prevent pressure ulcers.

Authors:  Brecht Serraes; Ann Van Hecke; Hanne Van Tiggelen; Charlotte Anrys; Sofie Verhaeghe; Dimitri Beeckman
Journal:  Int Wound J       Date:  2020-06-30       Impact factor: 3.315

3.  Pediatric medical device development by surgeons via capstone engineering design programs.

Authors:  Bryan S Sack; Rodolfo A Elizondo; Gene O Huang; Nicolette Janzen; Jimmy Espinoza; Magdalena Sanz-Cortes; Jennifer E Dietrich; Julie Hakim; Eric S Richardson; Maria Oden; John Hanks; Balakrishna Haridas; James F Hury; Chester J Koh
Journal:  J Pediatr Surg       Date:  2017-02-06       Impact factor: 2.545

Review 4.  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

5.  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

6.  Comparison of high-resolution X-ray and micro-CT for experimental evaluation of intracranial stent prototypes: quality evaluation beyond CE mark.

Authors:  Andreas Keuler; Christian Taschner; Marc Alexander Brockmann; Hanne Boll; Katharina Förster; Lisa Lutz; Annegret Herrmann-Frank; Monika Lelgemann; Martin Schumacher
Journal:  Neuroradiology       Date:  2014-01-31       Impact factor: 2.804

Review 7.  Approaches to assessing the benefits and harms of medical devices for application in surgery.

Authors:  Stefan Sauerland; Anne Catharina Brockhaus; Naomi Fujita-Rohwerder; Stefano Saad
Journal:  Langenbecks Arch Surg       Date:  2014-02-16       Impact factor: 3.445

8.  Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

Authors:  Lutz Heinemann; G Alexander Fleming; John R Petrie; Reinhard W Holl; Richard M Bergenstal; Anne L Peters
Journal:  Diabetologia       Date:  2015-03-18       Impact factor: 10.122

9.  Incentivizing research into the effectiveness of medical devices.

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

Review 10.  The Role of the FDA and Regulatory Approval of New Devices for Diabetes Care.

Authors:  Shelley A Jazowski; Aaron N Winn
Journal:  Curr Diab Rep       Date:  2017-06       Impact factor: 4.810
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