Abbott wins FDA nod for Confirm Rx smartphone-connected cardiac monitor

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Abbott (NYSE:ABT) said today it won FDA clearance for its Confirm Rx insertable cardiac monitor, touting it as the 1st and only smartphone compatible ICM designed to help identify cardiac arrhythmias.

The Confirm Rx system includes a sensor designed to be implanted just under the skin over the chest in a minimally-invasive outpatient procedure, the company said.

The newly cleared device features incorporated Bluetooth wireless technology to allow patients to connect to the device on their smartphone devices through Abbott’s myMerlin mobile application. Data collected by the device is also transmitted to the patient’s physician on a schedule set by the practitioner, the company said.

“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. 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,” cardiac rhythm management biz medical director Dr. Avi Fischer said in a press release.

The company’s associated myMerlin app allos patients to track symptoms and sync data with their clinics at any time as well as viewing transmission history to confirm data transfer without havin to contact their clinci. All transfers are encrypted using the “highest standards in mobile security,” Abbott said.

Last week, Abbott saw share prices tick up in pre-market trading after the healthcare giant posted sales and profits that beat the consensus forecast on Wall Street.

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