Boston Scientific earned approval from the Food and Drug Administration for its Emblem MRI Subcutaneous Implantable Defibrillator.
The Emblem MRI S-ICD is a third generation device that contains additional capabilities, including SMART Pass technology to make sure defibrillation therapy is administered only when needed and an AF Monitor that informs clinicians about atrial fibrillation episodes.
The new additions are available for patients with already implanted defibrillators via a software update.
The approval also includes magnetic resonance conditional labeling, allowing patients with the implanted device to safely undergo MR scans.
While Boston Scientific launched the device in Europe in June, Marlborough, Mass.-based company did not state when it expects the device to be available in the United States.
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