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Medtronic: FDA Approves Expanded Indication For LINQ II ICM For Use In Pediatric Patient Population

Medtronic plc (MDT) announced the LINQ II Insertable Cardiac Monitor system is the first-and-only ICM to receive 510(k) clearance by the 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 for patients with abnormal heart rhythms who experience infrequent symptoms including dizziness, palpitations, syncope and chest pain, requiring long-term monitoring or ongoing management. 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.

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