Smartphone compatible cardiac monitor clears FDA approval

Abbott has secured 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. By incorporating Bluetooth® wireless technology, Abbott has advanced remote monitoring by allowing patients to connect their ICM to their smartphone via the myMerlinTM 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.

Comments 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.