Technology | Implantable Cardiac Monitor (ICM) | October 23, 2017

First Smartphone Compatible Insertable Cardiac Monitor Cleared by FDA

Confirm RX ICM allows patients to be monitored remotely with a Bluetooth connection to their mobile phone

Abbott SJM St. Jude Confirm RX implantable cardiac monitor (ICM).

October 23, 2017 – The U.S. Food and Drug Administration (FDA) has cleared Abbott’s Confirm Rx Insertable Cardiac Monitor (ICM), the world's first smartphone compatible ICM designed to help physicians remotely identify cardiac arrhythmias. The technology provides U.S. patients with a new way to monitor for abnormal heart rhythms while staying connected to their physician remotely and being able to engage in their healthcare.

"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," said Avi Fischer, M.D., divisional vice president and medical director of Abbott's cardiac rhythm management business. "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's insertable cardiac monitors have helped advance how physicians remotely monitor patients for abnormal heart rhythms. By incorporating Bluetooth wireless technology, Abbott has advanced remote monitoring by allowing patients to connect their ICM to their smartphone via the myMerlin mobile app. Once implanted just under the skin in the chest during a quick, minimally invasive outpatient procedure, the Confirm Rx continuously monitors heart rhythms to detect a range of cardiac arrhythmias, including irregular heartbeats or atrial fibrillation (AF or Afib).

Data collected by the device is then securely transmitted to a patient's physician via the mobile app on a schedule set by the clinic. 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.

The ICM can be used in place of a a patient-worn Holter monitor, especially for patient requiring long-term monitoring. 


Benefits of the Confirm Rx ICM

The Confirm Rx ICM is the world's first insertable cardiac monitor that combines a quick and minimally invasive procedure with a device that uses Bluetooth wireless technology, allowing patients to connect using a mobile app downloaded to their own smartphone. 

The device and mobile app are designed to allow for:
   • Continuous heart monitoring using the patient's smartphone to record episodes of irregular heartbeat.
   • The ability for patients to easily send their heart rhythm information to their doctor without interrupting daily activities.
   • A discreet implant—the slimmest insertable cardiac monitor available today.

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.

The Confirm Rx ICM limits communication to a single authenticated myMerlin mobile app. The Confirm Rx ICM and the myMerlin mobile app encrypt all wireless communications using the highest standards in mobile security.

St, Jude Medical (SJM) developed the Confirm RX. Abbott Purchased SJM in January. 

For more information:


Related Implantable Cardiac Monitor Articles and Videos:

Confirm RX First Implantable Cardiac Monitor to Gain Approval Using Mobile Phone App Monitoring

VIDEO: Editor's Choice of Most Innovative New Technology at ACC.17

Implantable Cardiac Monitors Detect High Rate of Atrial Fibrillation in Previously Undiagnosed High-Risk Patients

What is New in Electrophysiology Technologies

VIDEO: Editor's Choice of Most Innovative New Technology at HRS 2017

VIDEO: Advances in Electrophysiology Technology

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