Boston Sci’s EMBLEM MRI Subcutaneous Implantable Defibrillator FDA Approved

Boston Scientific won FDA approval for its EMBLEM MRI Subcutaneous Implantable Defibrillator (S-ICD), as well as retroactive magnetic resonance (MR) conditional labeling for already implanted EMBLEM S-ICDs. The new regulatory decision will allow patients sporting these devices to continue to be protected from cardiac arrest even while inside an MRI machine.

The new system includes SMART Pass technology, which can also be added to existing devices via a software update, that improves the accuracy of shock delivery so it's only done when necessary. Additionally, the new AF Monitor feature detects atrial fibrillation events and reports those to the patient's cardiologist for closer inspection.

Flashbacks: Subcutaneous Implantable Cardiac Defibrillator FDA Approved…

Product page: EMBLEM S-ICD…

Source: Boston Scientific…

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