> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA OKs Boston Scientific Emblem MRI-friendly Defibrillator
- URL: https://www.fdaweb.com/fda-oks-boston-scientific-emblem-mri-friendly-defibrillator/
- Published: 2016-08-09T12:00:00.000Z
- Updated: 2026-09-14T21:23:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136456

FDA has approved a Boston Scientific PMA for the Emblem MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted Emblem S-ICD Systems. “Now with FDA approval, patients receiving the Emblem MRI S-ICD System, as well as patients who previously were implanted with an Emblem S-ICD System, have reassurance they can safely undergo MR scans while remaining protected from cardiac arrest,” the company says.

The device features SMART Pass technology and an atrial fibrillation (AF) monitor. The SMART Pass technology, which is also being added to previously implanted Emblem S-ICD Systems through a software update, increases the accuracy of the company’s INSIGHT Algorithm to help ensure patients receive appropriate therapy from the device only when necessary. The AF monitor feature is a detection tool designed to alert physicians after an AF event so they can make more informed treatment decisions for their patients.