FDA Clears Medtronic’s LINQ II™ ICM System for Use in Pediatric Patients Over the Age of 2

Medtronic announced the LINQ II™ Insertable Cardiac Monitor (ICM) system is the first-and-only ICM to receive 510(k) clearance by the U.S. FDA for use in pediatric patients over the age of 2 who have heart rhythm abnormalities and require long-term, continuous monitoring.

The LINQ II system is a small wireless ICM with a battery life of up to 4.5 years for patients with abnormal heart rhythms, allowing patients to undergo magnetic resonance imaging (MRI) and does not interfere with daily activities such as showering, bathing, or swimming. The latest-generation device has been implanted in thousands of patients globally since 2020.

Physicians will be able to provide actionable data to help diagnose underlying heart conditions and define treatment protocols in our younger patients with abnormal heart rhythms,” said Julie Brewer, president of the Cardiovascular Diagnostics and Services business, which is part of the Cardiovascular Portfolio at Medtronic.

The LINQ II ICM system also includes the recently launched AccuRhythm™ AI algorithms, improving the accuracy of information physicians receive.

With integrated remote patient management, patients or their caregivers can choose to use their smartphones with the LINQ II ICM to automatically transfer device data via the MyCareLink Heart™ mobile app using BlueSync™ technology that enables secure communication via Bluetooth.