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  • Posts tagged "medical devices" (Page 3)

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Sex comparison of diagnostic accuracy of CTA for CAD

September 1, 2012 / SGWHC Editorial Team / Journal Articles

Results from the Multicenter ACCURACY trial Background     The diagnosis of coronary artery disease (CAD) in women remains a challenge, given their lower prevalence of obstructive disease and the suboptimal performance of traditional noninvasive tests (exercise electrocardiography and stress myocardial perfusion imaging). Coronary computed tomographic angiography (CTA) is a validated method for detection and exclusion of […]

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Cardiology, CVD, Diagnostics, medical devices

FDA Draft Guidance on Medical Devices

August 31, 2012 / SGWHC Editorial Team / Guidelines/Statements

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FDA, medical devices

Evaluating Sex Differences in Medical Device Clinical Trials: Time for Action

April 27, 2012 / SGWHC Editorial Team / Blog

The Safety and effectiveness of medical treatments can differ in men and women for many reasons related to different epidemiologic characteristics, physiology, and body size. In general, women have higher bleeding rates and procedural morbidity and mortality than men, which means that their risk/benefit ratios for many implanted medical devices can differ from men. Therefore, […]

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medical devices

Sex Differences in Medical Devices

April 5, 2012 / SGWHC Editorial Team / Journal Articles, Resources

Evaluating Sex Differences in Medical Device Clinical Trials (Editorial) by SS Dhruva & RF Redberg Medical Treatments Editorial Druma and Redberg

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medical devices
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