Cardiac patients in 10 European countries now have greater freedom and mobility thanks to the recent CE approval of Abbott‘s Confirm Rx ICM insertable cardiac monitor. Previously patients who were discharged from the hospital but required remote monitoring were restricted to bulky bedside or handheld transmitters. According to Abbott, Confirm RX ICM is appropriate for monitoring indicators such as syncope, palpitations, and atrial fibrillation. Confirm RX ICM is a 1.9-inch long, 0.37-inch wide, 0.12-inch deep device that weighs just 3 grams, or about one-tenth of an ounce. The device is inserted into the patient’s chest by a physician. The ICM automatically transfers pertinent cardiac data via wireless technology to an iOS or Android smartphone running Abbott’s myMerlin app. The app sends the data in encrypted form via cellular or Wi-Fi networks to the Merlin.net Patient Care Network where it can be accessed by clinicians. The passive nature of the ICM device benefits patients and clinicians. The monitor is already in place, continuously transmitting data. Patients are empowered by the myMerlin app’s simple interface and the freedom to move or travel. They can also annotate symptoms in the app and, unlike traditional transmitters that synchronize data nightly, send data and annotations directly to a clinic whenever they feel the need. According to Abbott, Confirm RX ICM will be released throughout Europe during the second quarter of 2017. The device is currently under review by the FDA.
Healthcare technology firm Abbott has been granted Conformité Européene approval for its Confirm RX ICM cardiac monitor. The device is designed to be used in the field by healthcare professionals and patients alike. The Confirm RX ICM will be launched during Q2 2017. The device is currently awaiting the approval of the US Food and Drug Administration.