Reveal LINQ Insertable Cardiac Monitor receives FDA 510(k) clearance for diagnostics in heart arrhythmia- Medtronic

Medtronic announced FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection, an advanced cardiac monitor offering improved accuracy to better identify abnormal heartbeats. Reveal LINQ ICM with TruRhythm Detection offers exclusive algorithms that result in a 95 percent reduction in false bradycardia (slow heartbeat) episodes and a 47 percent reduction in false pause (brief absence of cardiac activity) episodes when compared with its predecessor, the Reveal LINQ ICM. The device also features a self-learning atrial fibrillation (AF - an irregular and often very fast heart rate) algorithm, which learns and adapts to a patient's heart rhythm over time.

AF episodes, which are most likely to trigger false positives with ICMs, experienced a 49 percent reduction in false detections with the Reveal LINQ ICM with TruRhythm Detection when compared to the Reveal LINQ ICM.