Abbott said its Confirm Rx Insertable Cardiac Monitor (ICM), a smartphone compatible ICM to help physicians identify cardiac arrhythmias remotely, has been cleared by the U.S. Food and Drug Administration (FDA).
Arrhythmias are abnormal heart patterns that can occur after disease or injury when the heart’s electrical patterns have been disturbed. This causes problems such as palpitations, dizziness, shortness of breath or fainting.
With the FDA clearance, Abbott can deliver a product that keeps physicians and their patients connected even when the patient is not in for a visit, Abbott said in a release. The physician will be able to monitor abnormal heart rhythms from a remote location.
"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 the 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 heart beats without requiring the patient to use a separate or cumbersome recording device."