Tag: defibrillator

A company-initiated recall of two models of EMBLEM S-ICD (Boston Scientific) subcutaneous implantable cardioverter defibrillator pulse generators has been categorized as Class I by the US Food and Drug Administration (FDA), the agency announced today. The FDA notes that the advisory, which was communicated to patients and doctors in December, applies to 2825 of the

An international clinical trial that studied wearable cardioverter defibrillators (WCDs) found that the devices did not significantly reduce sudden cardiac death—the primary goal of the device—among patients assigned to the device in the first 90 days after a heart attack, but did lower mortality among those who wore it as prescribed, according to a study