Medtronic Receives FDA Clearance For First Insertable Cardiac Monitor Indication For Pediatric Patients

The FDA granted 510(k) clearance to Medtronic plc's MDT LINQ II Insertable Cardiac Monitor (ICM) system for use in pediatric patients over the age of 2 who have heart rhythm abnormalities and require long-term, continuous monitoring.
The LINQ II ICM is the first continuous, long-term cardiac monitor cleared by FDA for the pediatric patient population.
Also Read: Medtronic Recalls HeartWare HVAD System Batteries For Electrical Faults.
The LINQ II system is a small (one-third the size of a AAA battery) wireless ICM for patients with abnormal heart rhythms who experience infrequent symptoms.
The LINQ II ICM, which has a battery life of up to 4.5 years, allows patients to undergo magnetic resonance imaging (MRI) when needed and does not interfere with daily activities.
The LINQ II ICM system also includes the recently launched AccuRhythm AI algorithms.
The two AI algorithms have been shown to reduce the number of false alerts specific to the most common ICM false alerts while preserving more than 99% of true alerts.
Price Action: MDT shares are down 0.96% at $88.82 on the last check Tuesday.
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