FDA Clears First Smartphone Compatible Insertable Cardiac Monitor

The monitor works – via Bluetooth – with the free ‘myMerlin’ mobile app to continuously monitor the hearts rhythms
The monitor works – via Bluetooth – with the free ‘myMerlin’ mobile app to continuously monitor the hearts rhythms

The first smartphone compatible insertable cardiac monitor (ICM), the ‘Confirm Rx' (Abbott), has been cleared for use by the Food and Drug Administration (FDA).

The Confirm Rx ICM is implanted under the skin in a minimally-invasive outpatient procedure. Afterwards, the monitor works – via Bluetooth – with the free ‘myMerlin' mobile app which allows patients to continuously monitor for abnormal heart rhythms. The data can then be securely transmitted to a physician through the mobile app on a schedule arranged by the clinic. 

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The app allows patients to track symptoms proactively and view transmission history without having to contact the clinic to confirm data transfers. A data sync to the clinic can be instigated at any time by the patient.

“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,” said Avi Fischer, MD, medical director of Abbott Cardiac Rhythm Management.

All wireless communications on the myMerlin app are encrypted and Confirm Rx limits communication to one single confirmed app.

For more information visit Abbott.com.