Boston Scientific (NYSE:BSX) has received FDA 510(k) clearance for the LUX-Dx Insertable Cardiac Monitor (ICM) System, a new, long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation, cryptogenic stroke and syncope.
The new LUX-Dx ICM System is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making.
The company will immediately begin a limited market release of the LUX-Dx ICM System in the U.S., with full launch commencing later this year.
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