This Viewpoint discusses creation of a US evaluation system for health technology that could quickly identify problematic devices, accurately and transparently characterize and disseminate information about device performance in clinical practice, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices.
This randomized clinical trial compares the effects of use vs nonuse of a cerebral embolic protection device during transcatheter aortic valve implantation (TAVI) on MRI-detected brain lesions in patients with severe aortic stenosis undergoing TAVI.
This Medical News features describes advances in the development of wearable biosensors that can monitor health indicators such as levels of blood glucose or electrolytes.
This Viewpoint discusses the conceptual framework of the Precision Medicine Initiative that could lead to improved health by more effectively matching medical products to the needs and preferences of patients and care partners.
This Viewpoint proposes implementation of strategic coordinated registries networks as the foundation for a national surveillance system that inform decisions about medical device safety, effectiveness, and quality.
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.
This Viewpoint discusses issues that prevent wearable medical devices from effectively bridging the gap between recording information and changing health-related behavior.
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.