Abbott smartphone-compatible cardiac monitor gains CE Mark

Abbott announced its smartphone-compatible insertable cardiac monitor (ICM) has gained CE Mark. The device allows physicians to remotely monitor patients, potentially diagnosing arrhythmias and atrial fibrillation (AFib).

After downloading to a patient’s smartphone, the ICM continuously monitors heart rhythm and transmits data to physicians via Abbott’s MyMerlin application. The ICM also can alert users to missed transmissions.

"The Confirm Rx ICM device will be an important tool for diagnosing patients with suspected arrhythmias, such as those who have experienced fainting or palpitations," said Georg Nölker, MD, head of electrophysiology at Ruhr-University of Bochum, Germany. "The simple insertion procedure and small device size make this technology convenient for both patients and providers. Patients can record symptoms directly on their smartphone without the need for a bedside transmitter or separate activator."

Patients can record symptoms on their own smartphone and specify events such as fainting or increased heart rate. The secure data transmission could eliminate follow-ups from physicians.

"Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance," said Mark D. Carlson, MD, chief medical officer of Abbott's cardiac arrhythmias and neuromodulation businesses. "The Confirm Rx ICM addresses a broad range of indications, such as syncope, palpitations and atrial fibrillation. The technology has been designed with robust data privacy and security measures to ensure peace of mind for both patients and providers."

The device is under review by the U.S. Food and Drug Administration.