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First FDA Approved Smartphone Compatible Insertable Cardiac Monitor

The FDA has now cleared Abbott’s Confirm Rx™ Insertable Cardiac Monitor (ICM), the world’s first and only smartphone compatible ICM designed to help physicians remotely identify cardiac arrhythmias.

An arrhythmia is definitely an abnormal heart rhythm that develops when disease or injuries disrupts the heart’s electrical signals, resulting in the heart to conquer erratically. Because the heart starts to beat too quickly or not fast enough, alterations in bloodstream flow can expose patients to signs and symptoms for example palpitations, dizziness, difficulty breathing or fainting.

Now with the FDA’s green light, the device can be employed by doctors in the US to remotely monitor for abnormal heart rhythms. The device earned a CE mark in Europe in May this year.

First FDA Approved Smartphone Compatible Insertable Cardiac Monitor
Confirm-Rx

The Confirm Rx ICM, which is implanted just underneath the skin in the chest during a minimally invasive outpatient procedure, is paired with Abbott’s myMerlin mobile application. In the app, patients can record episodes of irregular heartbeat and send that information to their doctors, who have continuous access to data from the ICM.

Confirm Rx shows what we can do with cutting edge communication technology and the most advanced medical devices that provide new opportunities to improve patient care,

” Avi Fischer, MD, divisional vice president and medical director of Abbott’s Cardiac Rhythm Management business, said in a press release. “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 heartbeats without requiring the patient to use a separate or cumbersome recording device.

The app allows patients to record symptomatic events from their own smartphone without the need for additional hardware such as handheld activators or bedside transmitters.

The device and mobile app are designed to allow for continuous heart monitoring using the patient’s smartphone to record episodes of AF. It also enables the patient to send their heart rhythm information to their doctor without interrupting daily activities.

While the Confirm Rx ICM continuously monitors for abnormal heart rhythms and transmits data to a patient’s physician, the myMerlin app also allows patients to track symptoms proactively, sync their data with their clinic at any time, and view their transmission history without having to contact their clinic to confirm successful data transfers.

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