The FDA has granted 510(k) clearance to LUX-Dx Insertable Cardiac Monitor (ICM) System developed by Boston Scientific. LUX-DxICM System is a long-term diagnostic device implanted in patients to detect arrhythmias related to conditions, including atrial fibrillation (AF), cryptogenic stroke and syncope. Patients are provided with a mobile device preloaded with the MyLUX app after implant. The app offers physicians and care teams access to vital information by transmitting device data daily. Read more.