Literature DB >> 15226221

Medical device development: from prototype to regulatory approval.

Aaron V Kaplan1, Donald S Baim, John J Smith, David A Feigal, Michael Simons, David Jefferys, Thomas J Fogarty, Richard E Kuntz, Martin B Leon.   

Abstract

Mesh：

Year:  2004        PMID： 15226221     DOI： 10.1161/01.CIR.0000134695.65733.64

Source DB:  PubMed          Journal:  Circulation        ISSN： 0009-7322            Impact factor:   29.690


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  21 in total

1.  Rethinking medical device regulation.

Authors:  Carl Heneghan; Mathew Thompson
Journal:  J R Soc Med       Date:  2012-05       Impact factor: 5.344

Review 2.  Regenerative medicine: Current therapies and future directions.

Authors:  Angelo S Mao; David J Mooney
Journal:  Proc Natl Acad Sci U S A       Date:  2015-11-24       Impact factor: 11.205

Review 3.  In vivo imaging and computational analysis of the aortic root. Application in clinical research and design of transcatheter aortic valve systems.

Authors:  Paul Schoenhagen; Alexander Hill; Tim Kelley; Zoran Popovic; Sandra S Halliburton
Journal:  J Cardiovasc Transl Res       Date:  2011-04-12       Impact factor: 4.132

4.  Impact of alternative medical device approval processes on costs and health.

Authors:  Benjamin P George; Vinayak Venkataraman; E Ray Dorsey; S Claiborne Johnston
Journal:  Clin Transl Sci       Date:  2014-09-03       Impact factor: 4.689

5.  Innovation under Regulatory Uncertainty: Evidence from Medical Technology.

Authors:  Ariel Dora Stern
Journal:  J Public Econ       Date:  2016-11-23

Review 6.  Engineering therapies in the CNS: what works and what can be translated.

Authors:  Andrew J Shoffstall; Dawn M Taylor; Erin B Lavik
Journal:  Neurosci Lett       Date:  2012-02-04       Impact factor: 3.046

Review 7.  New challenges for intervertebral disc treatment using regenerative medicine.

Authors:  Koichi Masuda; Jeffrey C Lotz
Journal:  Tissue Eng Part B Rev       Date:  2010-02       Impact factor: 6.389

8.  Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices.

Authors:  Neil J Wimmer; Susan Robbins; Henry Ssemaganda; Erin Yang; Sharon-Lise Normand; Michael E Matheny; Naomi Herz; Josh Rising; Frederic S Resnic
Journal:  J Health Care Finance       Date:  2016

9.  Proceedings from Heart Rhythm Society's emerging technologies forum, Boston, MA, May 12, 2015.

Authors:  Emily P Zeitler; Sana M Al-Khatib; David Slotwiner; Uday N Kumar; Paul Varosy; David R Van Wagoner; Gregory M Marcus; Fred M Kusumoto; Laura Blum
Journal:  Heart Rhythm       Date:  2016-02       Impact factor: 6.343

10.  Postmarketing trials and pediatric device approvals.

Authors:  Thomas J Hwang; Aaron S Kesselheim; Florence T Bourgeois
Journal:  Pediatrics       Date:  2014-04-14       Impact factor: 7.124
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