On March 13, 2017, Medtronic announced FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection.

Previously, Medtronic received Ministry of Health, Labor and Welfare approval for the device in Japan during September 2016, launching the product shortly after. Medtronic now seeks to duplicate its successful launch in the United States.

As shown on the right, the Reveal LINQ ICM is

designed to be implanted just under the skin of a patient’s chest during a minimally invasive procedure. Once implanted, the monitor can help doctors properly diagnose and treat patients having an increased risk of cardiac arrhythmias and patients who experience symptoms, such as dizziness, palpitation, fainting or syncope, and chest pain that may be related to cardiac arrhythmia.

According to Medtronic’s press release, the device “offers exclusive algorithms that result in a 95 percent reduction in false bradycardia (slow heartbeat) episodes,” a 47 percent reduction in false pause (brief absence of cardiac activity) episodes,” and “a 49 percent reduction in false detections” of atrial fibrillation (AF) when compared with its predecessor.

To achieve these reductions, Medtronic’s next generation device “features a self-learning atrial fibrillation . . . algorithm, which learns and adapts to a patient’s heart rhythm over time.” According to Dr. James Allred of Greensboro, N.C.’s Cone Health Medical Group Heartcare, “The enhancements with the Reveal LINQ ICM with TruRhythm Detection make it smarter by streamlining device data review so physicians can make decisions more accurately and quickly for patients.”

To that end, Nina Goodheart, Vice President and General Manager of the Patient Monitoring & Diagnostics business at Medtronic, stated,

We collaborated with hundreds of clinicians and analyzed more than 50,000 ECGs allowing us to pinpoint how we could redesign our algorithms to improve detection specificity, without compromising sensitivity.

According to the press release, such collaborations have produced one of the world’s smallest cardiac monitors—the device is approximately one-third the size of a AAA battery. Because the device is so small, is MR-conditional, and can wirelessly connect to Medtronic’s network, Medtronic’s website states that the device allows a doctor to continuously monitor a patient for up to 3 years without removing the device.

As a result, Medtronic has continued its global launch of the product. According to Randy Lieberman, M.D., director of electrophysiology at Detroit Medical Center, the technology is going to help “reach more patients at risk for cardiac arrhythmias and help healthcare systems more efficiently manage difficult patient populations.”