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This FDA database study reports a lack of publicly available scientific evidence supporting substantial equivalence for medical devices and their predicates cleared by the FDA through the 501(k) process between 2008 and 2012.
This FDA website review characterizes the sample sizes, time to completion, and subsequent revisions of recent FDA postapproval studies.
In this viewpoint, Rising and Moscovitch describe the Food and Drug Administration’s Unique Device Identification System as a means to provide reliable post-market information about medical devices.
This perspective reviews evidence and arguments against identifying carotid stenosis in asymptomatic patients.
This metanalysis of outcomes for ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention reports an increased mortality in women likely attributable to sex differences in cardiovascular risk factors and other clinical variables.
Badri et al. describe the under-representation of women, elderly, and minority participants in the randomized trials that inform cardiovascular guidelines.
Interview with Diana M. Zuckerman, PhD, author of Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices, and Joshua Sharfstein, MD, author of Improving Medical Device Regulation: A Work in Progress
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Diabetes Medication Choice Decision Aid Demonstration Video
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JAMA Internal Medicine has several sections devoted to contemporary issues confronting internists.
Case studies of patients with challenging electrocardiograms.
Articles about how overuse of medical care may result in harm and how less intervention may lead to better health.
JAMA Internal Medicine is pleased to launch a new subsection of Perspectives, Teachable Moments, to bring attention to the harms that can result from medical overuse and from underuse of needed medical interventions. The format for submitting an entry is described here; manuscripts should be submitted here as usual. Note we need written permission from patients to include their story.
Articles addressing health care reform in JAMA Internal Medicine's Health Care Reform feature.
Articles from the JAMA Network
International translations of Author Video Interviews
Author Mara A. Schonberg, MD, MPH, discusses Development and Evaluation of a Decision Aid on Mammography Screening for Women 75 Years and Older.
Author Russell P. Harris, MD, MPH, discusses The Harms of Screening: A Proposed Taxonomy and Application to Lung Cancer Screening.
Author Karen J. Wernli, PhD, discusses Patterns of Breast Magnetic Resonance Imaging Use in Community Practice.
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