Literature DB >> 28379790

An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials.

Owen Faris1, Jeffrey Shuren1.   

Abstract

Mesh：

Year:  2017        PMID： 28379790     DOI： 10.1056/NEJMra1512592

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


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  32 in total

1.  Assessing Computational Model Credibility Using a Risk-Based Framework: Application to Hemolysis in Centrifugal Blood Pumps.

Authors:  Tina M Morrison; Prasanna Hariharan; Chloe M Funkhouser; Payman Afshari; Mark Goodin; Marc Horner
Journal:  ASAIO J       Date:  2019 May/Jun       Impact factor: 2.872

2.  Real-World Evidence: Promise and Peril For Medical Product Evaluation.

Authors:  Sanket S Dhruva; Joseph S Ross; Nihar R Desai
Journal:  P T       Date:  2018-08

Review 3.  Health Technology Assessments for Flash Glucose Monitoring and How to Use Them in Everyday Clinical Practice.

Authors:  Magnus Stueve; Oliver Schnell
Journal:  J Diabetes Sci Technol       Date:  2018-08-22

4.  The Use of Computational Modeling and Simulation to Create Virtual Patients: Application to Cardiac Pacing and Defibrillation Systems.

Authors:  Adam Himes
Journal:  J Cardiovasc Transl Res       Date:  2018-01-05       Impact factor: 4.132

5.  Lumbar model generator: a tool for the automated generation of a parametric scalable model of the lumbar spine.

Authors:  C E Lavecchia; D M Espino; K M Moerman; K M Tse; D Robinson; P V S Lee; D E T Shepherd
Journal:  J R Soc Interface       Date:  2018-01       Impact factor: 4.118

Review 6.  Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative.

Authors:  J Stephen Mikita; Jules Mitchel; Nicolle M Gatto; John Laschinger; James E Tcheng; Emily P Zeitler; Arlene S Swern; E Dawn Flick; Christopher Dowd; Theodore Lystig; Sara B Calvert
Journal:  Ther Innov Regul Sci       Date:  2020-06-22       Impact factor: 1.778

7.  Survey of the Routine Practice Limits for Physiologic and Technical Parameters Managed by Clinical Perfusionists during Adult Cardiopulmonary Bypass.

Authors:  Bruce Searles; Edward M Darling; Jeffrey B Riley; Jason R Wiles
Journal:  J Extra Corpor Technol       Date:  2020-09

8.  Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast.

Authors:  Mintsje de Boer; Flora E van Leeuwen; Michael Hauptmann; Lucy I H Overbeek; Jan Paul de Boer; Nathalie J Hijmering; Arthur Sernee; Caroline A H Klazen; Marc B I Lobbes; René R W J van der Hulst; Hinne A Rakhorst; Daphne de Jong
Journal:  JAMA Oncol       Date:  2018-03-01       Impact factor: 31.777

9.  In Silico Clinical Trials in the Orthopedic Device Industry: From Fantasy to Reality?

Authors:  Philippe Favre; Ghislain Maquer; Adam Henderson; Daniel Hertig; Daniel Ciric; Jeffrey E Bischoff
Journal:  Ann Biomed Eng       Date:  2021-05-10       Impact factor: 3.934

10.  Update regarding opportunities for orthopaedic surgeons to contribute to postmarket surveillance of potential safety issues for orthopaedic medical devices marketed in the United States.

Authors:  Vincent J Devlin
Journal:  Arthroplast Today       Date:  2017-10-16
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