This Viewpoint uses a 2017 US Food and Drug Administration (FDA) safety communication about the vulnerability of some cardiac pacemakers to malware to discuss medical device data security and patient safety more generally, and regulatory steps the FDA has and can take to combat the risks.
This study characterizes the quality of clinical studies and data used to support US Food and Drug Administration approval of modifications to high-risk medical devices.
This randomized clinical trial compares the efficacy and adverse effects of 2 cerebral embolic protection devices vs a shared control group in reducing ischemic central nervous system injury during surgical aortic valve replacement.
This randomized clinical trial compares the effect of preoperative levosimendan vs placebo on the incidence of postoperative low cardiac output syndrome in patients with low ventricular ejection fraction who were undergoing coronary artery bypass grafting with cardiopulmonary bypass.
This Viewpoint uses the example of gastric band failures to discuss how available data may be used more appropriately to detect problems in the safety and effectiveness of medical devices.
This randomized clinical trial evaluates whether a scalp cooling device is effective compared with no cooling for reducing alopecia in women with breast cancer undergoing chemotherapy.
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.
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