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

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.
  • Photo via Company

Posted In: BriefsFDA 510(k) ClearancePediatricsLarge CapNewsHealth CareFDAGeneral