Boston Scientific’s Insertable Cardiac Monitor Cleared

The FDA has granted Boston Scientific 510(k) clearance for its LUX-Dx insertable cardiac- monitor system, a device that monitors patients for arrhythmias.

The diagnostic device is implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation and syncope and cryptogenic stroke.

The system uses an algorithm that detects and verifies potential arrhythmias and then sends an alert to the clinician. It also allows healthcare professionals to remotely adjust its detection settings, reducing in-person appointments.