Boston Scientific Corporation (NYSE: BSX) said it received FDA approval for the EMBLEM MRI Subcutaneous Implantable Defibrillator (S-ICD) System and magnetic resonance (MR) conditional labeling for all its earlier implanted EMBLEM S-ICD Systems. The approval enabled the company to add the device to its growing line of ImageReady MR-conditional devices.
The company indicated the devices enable patients to undergo magnetic resonance imaging (MRI) safely. It claimed the system is a proved treatment option for patients, who are at a risk of sudden cardiac arrest.
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Boston Scientific's chief medical officer for Rhythm Management, Kenneth Stein, said, "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 got FDA approval for its ImageReady MR-Conditional Pacing System earlier in the current year. That included ESSENTIO and ACCOLADE MRI pacemakers and INGEVITY MRI pacing leads meant to treat bradycardia.
On Monday, the stock shed $0.26, or 1.06 percent, to $23.88.
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