WASHINGTON (dpa-AFX) - Boston Scientific (BSX) announced the company has received U.S. FDA approval for the EMBLEM MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance conditional labeling for all previously implanted EMBLEM S-ICD Systems. The company said its EMBLEM S-ICD System is a proven treatment option for patients at risk of sudden cardiac arrest.
Boston Scientific received CE Mark for the EMBLEM MRI S-ICD System earlier in the current year and began commercialization in Europe in June. Earlier in the current year, the company received FDA approval for the ImageReady MR-Conditional Pacing System designed to treat bradycardia.
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