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13 in total

Review 1. 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

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. Medical device postapproval safety monitoring: where does the United States stand?

Authors: Prashant V Rajan; Daniel B Kramer; Aaron S Kesselheim
Journal: Circ Cardiovasc Qual Outcomes Date: 2015-01-06

4. Registry-Based Prospective, Active Surveillance of Medical-Device Safety.

Authors: Frederic S Resnic; Arjun Majithia; Danica Marinac-Dabic; Susan Robbins; Henry Ssemaganda; Kathleen Hewitt; Angelo Ponirakis; Nilsa Loyo-Berrios; Issam Moussa; Joseph Drozda; Sharon-Lise Normand; Michael E Matheny
Journal: N Engl J Med Date: 2017-01-25 Impact factor: 91.245

5. 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

6. The data extraction and longitudinal trend analysis network study of distributed automated postmarket cardiovascular device safety surveillance.

Authors: Amit Kumar; Michael E Matheny; Kalon K L Ho; Robert W Yeh; Thomas C Piemonte; Howard Waldman; Pinak B Shah; Richard Cope; Sharon-Lise T Normand; Sharon Donnelly; Susan Robbins; Frederic S Resnic
Journal: Circ Cardiovasc Qual Outcomes Date: 2014-12-09

7. 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

8. Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012.

Authors: Jenny Hwang; Thomas J Hwang; Joseph B Ciolino
Journal: BMJ Open Date: 2015-06-04 Impact factor: 2.692

9. Advances in the Use of Real-World Evidence for Medical Devices: An Update From the National Evaluation System for Health Technology.

Authors: Rachael L Fleurence; Jeffrey Shuren
Journal: Clin Pharmacol Ther Date: 2019-03-19 Impact factor: 6.875

Review 10. Regulatory approval of new medical devices: cross sectional study.

Authors: Hani J Marcus; Christopher J Payne; Archie Hughes-Hallett; Adam P Marcus; Guang-Zhong Yang; Ara Darzi; Dipankar Nandi
Journal: BMJ Date: 2016-05-20