Abbott's smartphone compatible Confirm Rx insertable cardiac monitor gains FDA clearance

Abbott announced Monday that the FDA cleared the Confirm Rx insertable cardiac monitor, which the company said is the "world's first and only smartphone compatible ICM designed to help physicians remotely identify cardiac arrhythmias." The device gained the CE mark in May.

Avi Fischer, medical director of Abbott's cardiac rhythm management business, remarked that "by offering a device that uses Bluetooth wireless technology from the patient's smartphone, we can help physicians easily and remotely diagnose potentially dangerous abnormal heart beats without requiring the patient to use a separate or cumbersome recording device."

Abbott noted that once Confirm Rx is implanted it continuously monitors heart rhythms to detect cardiac arrhythmias, such as atrial fibrillation. The device enables the ICM to be connected to the patient's smartphone via the myMerlin mobile app, and data can be securely transmitted to a patient's physician via the app. Abbott added that "the app also allows patients to record symptomatic events from their own smartphone without the need for additional hardware such as handheld activators or bedside transmitters."

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