CE Mark granted for Confirm Rx Insertable Cardiac Monitor (ICM) to monitor cardiac arrhythmias.- Abbott.
Abbott announced CE Mark and first use of the new Confirm Rx Insertable Cardiac Monitor (ICM), the world's first smartphone compatible ICM that will help physicians identify difficult to detect cardiac arrhythmias, including atrial fibrillation (AF), to help guide therapy. Since CE Mark approval, adoption of the device has been strong and implants have occurred in 10 countries across Europe. The Confirm Rx ICM is designed to continuously monitor a patient's heart rhythm and proactively transmit information via the myMerlin mobile app, allowing physicians to follow their patients remotely and accurately diagnose arrhythmias.
Traditional remote monitoring has required bulky handheld or bedside transmitters, which limit patient mobility. The new interactive myMerlin mobile app replaces these passive transmitters and empowers patients to participate in their own care. In addition to patient convenience, the device is slimmer than currently available ICMs. The Confirm Rx ICM also offers intuitive one-touch indication-based programming, and remote monitoring via the Merlin.net Patient Care Network, making the technology convenient for clinicians involved in procedure and follow up.