Insertable cardiac monitor cleared by FDA for children aged more than 2 years
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Medtronic announced its insertable cardiac monitor received FDA 510(k) clearance for use in pediatric patients aged more than 2 years with arrhythmias requiring long-term, continuous monitoring.
The insertable cardiac monitoring system (LINQ II) is a small, wireless monitor for patients with arrhythmias who experience symptoms including dizziness, palpitations, syncope and chest pain, according to a company press release.
The monitor has a battery life of up to 4.5 years and patients can undergo MRI when needed, according to the release.
The system also includes a recently launched AI algorithm (AccuRhythm) to improve data accuracy reduce the number of false alerts, the company stated in the release.
In addition, patients or caregivers can choose to use the system’s smartphone compatibility to automatically transfer device data via mobile app (MyCareLink Heart) for secure communication via Bluetooth (BlueSync), according to the release.
"For pediatric cardiologists who see many young patients needing continuous, long-term monitoring for infrequent or unknown heart rhythm conditions, this expanded indication for the LINQ II ICM is critically important,” Jennifer Silva, MD, director of pediatric cardiac electrophysiology at Washington University in St. Louis and St. Louis Children’s Hospital, said in the release. "The data generated from these small monitors can help us better tailor treatment decisions and ongoing management for our patients.”
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