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Use of Cardiac Implantable Electronic Devices in Older Adults With Cognitive Impairment. Fowler et al.

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Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in the United States, 1999-2010. Bachhuber et al.

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Lack of Public Evidence About Implantable Devices

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.
Invited Commentary

Assessing the Safety and Efficacy of Devices

This FDA website review characterizes the sample sizes, time to completion, and subsequent revisions of recent FDA postapproval studies.
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The FDA's Unique Device Identification System

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.

Identifying Carotid Stenosis

This perspective reviews evidence and arguments against identifying carotid stenosis in asymptomatic patients.

Sex Differences in Mortality Among STEMI 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.

Underrepresentation of Women in Randomized Trials

Badri et al. describe the under-representation of women, elderly, and minority participants in the randomized trials that inform cardiovascular guidelines.

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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


Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices

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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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