Literature DB >> 23653340

Commentary: Europe needs a central, transparent, and evidence based regulation process for devices.

Michaela Eikermann1, Christian Gluud, Matthias Perleth, Claudia Wild, Stefan Sauerland, Iñaki Gutierrez-Ibarluzea, Sunya-Lee Antoine, Jacques Demotes-Mainard, Edmund A M Neugebauer.   

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Year:  2013        PMID： 23653340     DOI： 10.1136/bmj.f2771

Source DB:  PubMed          Journal:  BMJ        ISSN： 0959-8138


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  13 in total

1.  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

Review 2.  [Assessment of the benefit of medical devices in surgical practice. Problems and possible solutions].

Authors:  D Seidel; P Braß; N Sehnke; V Jakob; W Eglmeier; E A M Neugebauer
Journal:  Chirurg       Date:  2014-05       Impact factor: 0.955

3.  Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments.

Authors:  Claudia Wild; Judit Erdös; Ingrid Zechmeister
Journal:  BMC Cardiovasc Disord       Date:  2014-11-04       Impact factor: 2.298

4.  Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.

Authors:  Thomas J Hwang; Elisaveta Sokolov; Jessica M Franklin; Aaron S Kesselheim
Journal:  BMJ       Date:  2016-06-28

5.  What can we learn from publishing endoscopy trial protocols?

Authors:  Andreas Koutsoumpas; James E East
Journal:  Endosc Int Open       Date:  2016-02

6.  The Life Cycle of Health Technologies. Challenges and Ways Forward.

Authors:  Iñaki Gutiérrez-Ibarluzea; Marco Chiumente; Hans-Peter Dauben
Journal:  Front Pharmacol       Date:  2017-01-24       Impact factor: 5.810

Review 7.  The challenging landscape of medical device approval in localized prostate cancer.

Authors:  Massimo Valerio; Mark Emberton; Scott E Eggener; Hashim U Ahmed
Journal:  Nat Rev Urol       Date:  2015-12-15       Impact factor: 14.432

Review 8.  Exploring the reporting standards of RCTs involving invasive procedures for assisted vaginal birth: A systematic review.

Authors:  Emily J Hotton; Sophie Renwick; Erik Lenguerrand; Julia Wade; Tim J Draycott; Joanna F Crofts; Natalie S Blencowe
Journal:  Eur J Obstet Gynecol Reprod Biol       Date:  2021-05-14       Impact factor: 2.435

9.  A time-series study of percutaneous closure of patent foramen ovale: premature adoption?

Authors:  Kian Nian Lew; Gianni D Angelini; William Hollingworth
Journal:  Open Heart       Date:  2016-01-04

Review 10.  Specific barriers to the conduct of randomised clinical trials on medical devices.

Authors:  Edmund A M Neugebauer; Ana Rath; Sunya-Lee Antoine; Michaela Eikermann; Doerthe Seidel; Carsten Koenen; Esther Jacobs; Dawid Pieper; Martine Laville; Séverine Pitel; Cecilia Martinho; Snezana Djurisic; Jacques Demotes-Mainard; Christine Kubiak; Vittorio Bertele; Janus C Jakobsen; Silvio Garattini; Christian Gluud
Journal:  Trials       Date:  2017-09-13       Impact factor: 2.279
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