Boston Scientific Receives the US FDA’s 510(k) Clearance for its LUX-Dx Insertable Cardiac Monitor System

Shots:

• LUX-DxICM System is a dual-stage algorithm diagnostic device implanted in patients to identify AF, atrial flutter, rhythm pause, bradycardia, and tachycardia episodes and detect arrhythmias when established thresholds or parameters are exceeded
• The dual-stage algorithm verifies arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making. Additionally, after implant, patients are provided with a mobile device preloaded with the MyLUX app which connects via Bluetooth to their ICM device
• The app transmits device data daily/ as needed, to the LATITUDE Clarity Data Management System website providing remote programming capabilities to the device that enables physicians to adjust event detection settings without an in-person patient appointment

Click here to read full press release/ article | Ref: Boston Scientific | Image: The Boston Globe