Abbott’s smartphone compatible cardiac monitor gains CE Mark approval

Healthcare company Abbott has announced that its smartphone compatible Confirm Insertable Cardiac Monitor (ICM) has gained CE Mark approval.

The device is intended to help physicians recognise cardiac arrhythmias which are difficult to detect such as atrial fibrillation.

The company states that since CE Mark approval the device has seen strong adoption and implants have occurred in 10 countries across Europe.

Abbott’s Confirm ICM continuously monitors patients’ heart rhythm and transmits the information via a mobile app, allowing physicians to monitor their patients remotely and potentially accurately diagnose arrhythmias. By incorporating wireless technology Abbott has allowed the ICM to communicate directly to the app downloaded onto a patient’s smartphone.

The myMerlin mobile app allows healthcare professionals to omit bulky handhelds or bedside transmitters, which have previously been used for remote monitoring. Patients can have increased mobility due to the myMerlin mobile app which replaces passive transmitters.

Using the app patients can record their symptoms and specify events such as fainting or if they are experiencing a fast heart rate. Patients can also confirm their data was transmitted to their physician and get automatic alerts when they have missed a scheduled transmission, saving the clinician from having to follow up with the patient.

Georg Nölker, head of electrophysiology at the Herz-und Diabeteszentrum NRW, Ruhr-University of Bad Oeynhausen, Germany was one of the first physicians to use the ICM said: “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. 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.”

Mark D. Carlson, M.D., chief medical officer of Abbott’s cardiac arrhythmias and neuromodulation businesses said: “Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance. 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.”