Quality and transparency of clinical evidence for high-risk cardiovascular medical devices: a long way to go
Author:
Affiliation:
1. Center for Clinical Cardiology, National Institute of Medicine MSWiA , Wołoska 137, 02-507 Warsaw, Poland
2. Center of Postgraduate Medical Education , Warsaw , Poland
3. UCSF Division of Cardiology , SanFrancisco, CA , USA
Publisher
Oxford University Press (OUP)
Subject
Cardiology and Cardiovascular Medicine
Link
https://academic.oup.com/eurheartj/article-pdf/45/3/178/55676465/ehad786.pdf
Reference15 articles.
1. Medical device industry: international investigation exposes lax regulation;Lenzer;BMJ,2018
2. Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium;Siontis;Eur Heart J,2024
3. Increasing value and reducing waste: addressing inaccessible research;Chan;Lancet,2014
4. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices;Dhruva;JAMA,2009
5. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study;Hwang;BMJ,2016
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1. Focus on interventional cardiology: the need for quality and transparency of evidence for implantable cardiovascular medical devices;European Heart Journal;2024-01-14
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