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ImportanceAlthough outcomes in patients with ST-segment elevation myocardial infarction (STEMI) have improved in the past 2 decades, a sex disparity exists in survival, with women having higher mortality than men.
ObjectiveTo conduct a meta-analysis of observational studies that examined...
This Viewpoint describes the Food and Drug Administration’s unique device identification system for medical devices and recommends that federal agencies, specialty societies, and health care organizations collaborate to ensure that the system’s potential is fulfilled.
ImportanceUnder the 510(k) process, the US Food and Drug Administration (FDA) clears about 400 implanted medical devices that are considered moderate to high risk for market each year without requiring clinical testing. Instead, the FDA requires the applicant to provide scientific evidence that...
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