Abbott smartphone-compatible cardiac monitor gains FDA clearance

Abbott has received FDA clearance for its smartphone-compatible insertable cardiac monitor (ICM), the healthcare company announced Oct. 23. The device allows a patient to actively monitor his heart activity while giving physicians the ability to identify arrhythmias remotely.

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 heart beats without requiring the patient to use a separate or cumbersome recording device."

Abbott received CE mark approval for the device in May.