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 cohort study uses registry and Medicare claims data to assess the frequency of ICD implantation within 1 year of myocardial infarction and to compare mortality in patients with vs without ICDs.
Using the US FDA’s premarket approval (PMA) database, Rome and coauthors analyzed the prevalence and characteristics of changes to cardiac implantable electronic devices made through the PMA supplement process. In an Editorial, Goodman and Redberg discuss how FDA policies of transparency can help balance innovation and protection of public health.
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