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Items: 1 to 20 of 130

1.

Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.

Dhruva SS, Bero LA, Redberg RF.

JAMA. 2009 Dec 23;302(24):2679-85. doi: 10.1001/jama.2009.1899. Review. Erratum in: JAMA. 2010 Feb 3;303(5):422.

PMID:
20040556
2.

Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.

Kramer DB, Mallis E, Zuckerman BD, Zimmerman BA, Maisel WH.

Am J Ther. 2010 Jan-Feb;17(1):2-7. doi: 10.1097/MJT.0b013e3181ca8105.

PMID:
20038828
3.
4.
5.

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

Rome BN, Kramer DB, Kesselheim AS.

JAMA. 2014 Jan 22-29;311(4):385-91. doi: 10.1001/jama.2013.284986.

6.

Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices.

Dhruva SS, Bero LA, Redberg RF.

Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):165-71. doi: 10.1161/CIRCOUTCOMES.110.958215. Epub 2011 Mar 1. Review.

7.

Approval of high-risk medical devices in the US: implications for clinical cardiology.

Rome BN, Kramer DB, Kesselheim AS.

Curr Cardiol Rep. 2014;16(6):489. doi: 10.1007/s11886-014-0489-0. Review.

8.

Medical device recalls and the FDA approval process.

Zuckerman DM, Brown P, Nissen SE.

Arch Intern Med. 2011 Jun 13;171(11):1006-11. doi: 10.1001/archinternmed.2011.30. Epub 2011 Feb 14.

PMID:
21321283
11.

Evidence strength in FDA premarket approval of cardiovascular devices.

Kong DF, Hasselblad V, Krucoff MW.

JAMA. 2010 Apr 28;303(16):1599-600; author reply 1600-1. doi: 10.1001/jama.2010.511. No abstract available.

PMID:
20424248
12.

FDA regulation of cardiovascular devices and opportunities for improvement.

Dhruva SS, Redberg RF.

J Interv Card Electrophysiol. 2013 Mar;36(2):99-105. doi: 10.1007/s10840-012-9767-1. Epub 2012 Dec 21.

PMID:
23263896
13.

Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.

Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS.

JAMA. 2014 Jan 22-29;311(4):368-77. doi: 10.1001/jama.2013.282034.

14.

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

Reynolds IS, Rising JP, Coukell AJ, Paulson KH, Redberg RF.

JAMA Intern Med. 2014 Nov;174(11):1773-9. doi: 10.1001/jamainternmed.2014.4194.

PMID:
25265209
15.

Assessment of cardiovascular and noncardiovascular medical device recalls.

Somberg JC, McEwen P, Molnar J.

Am J Cardiol. 2014 Jun 1;113(11):1899-903. doi: 10.1016/j.amjcard.2014.03.024. Epub 2014 Mar 17.

PMID:
24837271
16.
17.

FDA's perspectives on cardiovascular devices.

Chen EA, Patel-Raman SM, O'Callaghan K, Hillebrenner MG.

J Cardiovasc Transl Res. 2009 Jun;2(2):143-6. doi: 10.1007/s12265-009-9096-7. Epub 2009 Mar 10. Review.

PMID:
20559979
18.

Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration.

Rathi VK, Ross JS, Samuel AM, Mehra S.

Otolaryngol Head Neck Surg. 2015 Sep;153(3):400-8. doi: 10.1177/0194599815587508. Epub 2015 Jun 4.

PMID:
26044785
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20.

Postmarketing trials and pediatric device approvals.

Hwang TJ, Kesselheim AS, Bourgeois FT.

Pediatrics. 2014 May;133(5):e1197-202. doi: 10.1542/peds.2013-3348. Epub 2014 Apr 14.

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