FDA clears Abbott’s smartphone-compatible cardiac monitor implant

By Dave Muoio
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The FDA has cleared Abbott’s Confirm Rx Insertable Cardiac Monitor (ICM), an implantable device that continuously tracks patients’ heart rhythms and sends the data to a smartphone app via Bluetooth. With the clearance, Abbott will soon be rolling out the device in the US.

The Confirm Rx ICM is placed just under the skin of the chest in a minimally-invasive outpatient procedure. Encrypted data from the device is coordinated by the myMerlin mobile app, then sent from the patient’s phone to a physician at predetermined intervals. In addition, users can also directly record symptomatic cardiac events through the app without the need for additional hardware, sync data at any time, and view their transmission history without having to contact their corresponding clinic.

"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," Dr. Avi Fischer, divisional vice president and medical director of Abbott's Cardiac Rhythm Management business, said in a statement. "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 has made quite a few strides into mobile health, most recently with last month’s FDA clearance of its fingerstick-free continuous glucose monitoring device. According to the company, its Confirm Rx will be the first smartphone-compatible ICM available in the US, and will also be the slimmest implantable ICM on the market.

Still, there are a number of phone-friendly cardiac monitors available that reside outside of the user’s body. In June, the FDA cleared Berkeley, California-based Eko Devices’ Duo, a combination of a digital stethoscope and portable electrocardiogram (ECG) that also syncs with companion app. This Spring, the agency also cleared Kirkland Washington-based Cardiac Insight’s Bluetooth-connected ECG recorder that can be worn outside of the users body for seven days, the Stealth System S300. On the other hand, iRhythm’s popular Zio patch ECG requires users to return the monitor by mail, and interacts with a user’s phone to enable symptom reporting.