This randomized clinical trial of 4524 patients undergoing transfemoral coronary angiography reports that vascular closure devices were noninferior to manual compression in terms of vascular access-site complications and reduced time to hemostasis.
This study uses data from ClinicalTrials.gov and FDA documents to report the proportion of high-risk therapeutic devices approved through the FDA’s Premarket Approval pathway that undergo postapproval study, as well as characteristics of those studies.
Using the US FDA’s premarket approval (PMA) database, Rome and coauthors analyzed the prevalence and characteristics of changes to cardiac implantable electronic devices made through the PMA supplement process. In an Editorial, Goodman and Redberg discuss how FDA policies of transparency can help balance innovation and protection of public health.
This Special Communication compares investment in medical research in the United States and other developed countries over the past 2 decades by quantifying total public and private investment and personnel and evaluating resulting patents, publications, drug and device approvals, and value created.