News & Updates

Boston Scientific wins FDA clearance for its LUX-Dx Insertable Cardiac Monitor

Boston Scientific has announced winning FDA clearance for its LUX-Dx Insertable Cardiac Monitor (ICM), an implant that can detect hard-to-spot cardiac arrhythmias, such as atrial fibrillation, and help diagnose their origin.

The device’s detection algorithm has two separate components, one of which detects a suspect arrhythmia and the other verify the finding. Once an arrhythmia is confirmed, the wireless device sends a signal to the patient’s cardiologist via an app installed on the patient’s phone. Having a double-checking component within the implant’s brains helps to prevent false positive alarms.

To help cardiologists get the most out of the monitor, and as a side benefit during the ongoing COVID-19 pandemic, the LUX-Dx can be re-programmed by the physician remotely to adjust its arrhythmia detection settings. Other similar devices involve patients visiting their doctors for a change in programming to happen.

The device can spot atrial fibrillation (AFib), rhythm pause, atrial flutter, bradycardia, and tachycardia within certain parameters that are defined by the physician.

“For physicians, receiving accurate monitoring data and having remote access to programming provides the opportunity to operate with more efficiency and confidence,” said Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific, in a press release. “The LUX-Dx ICM System is designed to provide physicians the ability to accelerate critical clinical decisions and allow them to spend more time focusing on patient outcomes by reviewing monitoring data and catching false positive detections without compromising sensitivity.”