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Boston Scientific Gets FDA 510(k) Clearance For LUX-Dx Insertable Cardiac Monitor System

Boston Scientific Corp. (BSX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LUX-DxInsertable Cardiac Monitor (ICM) System, a new, long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope.

This is the first ICM device with remote programming paired with dual-stage arrhythmia detection algorithm. It then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making.

Further, the remote programming capabilities of the device via the LATITUDE Clarity Data Management System website allow physicians and care teams to adjust event detection settings without requiring an in-person patient appointment, a feature unavailable on any other ICM currently on the market.

The dual-stage algorithm within the LUX-Dx ICM System can be programmed to identify AF, atrial flutter, rhythm pause, bradycardia and tachycardia episodes and allows the device to detect arrhythmias each time established thresholds or parameters are exceeded.

The company will immediately begin a limited market release of the LUX-Dx ICM System in the U.S. with full launch of the product commencing later this year.

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