• Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx™ Insertable Cardiac Monitor System

    First ICM device with remote programming paired with dual-stage arrhythmia detection algorithm
     

    MARLBOROUGH, Mass.June 29, 2020 /PRNewswire/ -- Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (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 (AF), 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. 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.

    MARLBOROUGH, Mass.June 29, 2020 /PRNewswire/ -- Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (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 (AF), 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. 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.

     

     

    Source:

    https://news.bostonscientific.com/2020-06-29-Boston-Scientific-Receives-FDA-510-k-Clearance-for-the-LUX-Dx-TM-Insertable-Cardiac-Monitor-System

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Review our Privacy Policy for more details