Abbott Launches First and Only Smartphone Compatible Insertable Cardiac Monitor in U.S.

Physicians can remotely monitor their patients with Confirm Rx for even the most difficult to detect cardiac arrhythmias, including irregular heartbeats.

Abbott (No. 10 on the DiversityInc Top 50 Companies list ) has secured U.S. Food and Drug Administration (FDA) clearance for the Confirm Rx Insertable Cardiac Monitor (ICM), the world's first and only smartphone compatible ICM designed to help physicians remotely identify cardiac arrhythmias. With FDA clearance Abbott can now provide U.S. patients a new way to monitor for abnormal heart rhythms while staying connected to their physician remotely and being able to engage in their health care.


An arrhythmia is an abnormal heart rhythm that develops when disease or injury disrupts the heart's electrical signals, causing the heart to beat erratically. As the heart begins to beat too fast or too slow, changes in blood flow can expose patients to symptoms such as palpitations, dizziness, shortness of breath or fainting.

"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—Confirm Rx continuously monitors heart rhythms to detect a range of cardiac arrhythmias, including irregular heartbeats, or atrial fibrillation.

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 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.

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Abbott's Xience Sierra Heart Stent Receives National Reimbursement in Japan to Treat People with Coronary Artery Disease

Coronary artery disease is the most common form of heart disease, which is the second leading cause of death in Japan.

Originally Published by Abbott.

Abbott announced that Japan's Ministry of Health Labour and Welfare (MHLW) granted national reimbursement for XIENCE Sierra™, the newest generation of the company's gold-standard XIENCE everolimus-eluting coronary stent. XIENCE Sierra improves upon previous versions of XIENCE with an enhanced stent design, a new delivery system, and unique sizes to help doctors treat challenging cases.

XIENCE Sierra was designed to help doctors more easily treat people with difficult-to-treat blockages that involve multiple or totally blocked arteries or complications such as diabetes. Complex cases are increasingly prevalent as people with coronary artery disease are living longer.

"Extensive clinical data and 10 years of real-world experience with the XIENCE family of stents provide doctors with confidence that they are treating their patients with one of the safest stents available," said Chuck Brynelsen, senior vice president of Abbott's vascular business. "National reimbursement of XIENCE Sierra will provide people in Japan with greater access to this life-changing technology that can help them live their best lives."

Coronary artery disease is the most common form of heart disease, which is the second leading cause of death in Japan. National reimbursement in Japan will enable doctors to treat more patients with XIENCE Sierra through the country's health insurance plans. XIENCE Sierra was approved in Japan on April 4, 2018, received CE Mark in Europe late last year, and is under review with the U.S. Food and Drug Administration.

XIENCE has been studied in over 100 clinical trials and in 10 years of global real-world experience. Its safety profile is unprecedented with consistent low rates of stent thrombosis, even in complex cases. More than eight million people worldwide have received a XIENCE stent since its initial regulatory approval.