19 May 2023

FDA clears Abbott's Assert-IQ insertable cardiac monitor, enabling long-term heart rhythm monitoring by physicians


The latest addition to Abbott's portfolio of connected health devices, Assert-IQ enables long-term monitoring and remote programming, enhancing connectivity with patients. Its continuous monitoring capabilities for abnormal heart rhythms are complemented by tools designed to improve data management and workflow within physicians' practices.


Abbott has received U.S. Food and Drug Administration (FDA) clearance for the Assert-IQ insertable cardiac monitor (ICM), providing physicians with a diagnostic evaluation and long-term monitoring option for individuals experiencing irregular heartbeats. This FDA clearance expands Abbott's range of connected health devices, empowering doctors to better manage and treat their patients remotely.


The Assert-IQ ICM incorporates Bluetooth technology, enabling it to remain connected to a transmitter, typically the patient's phone. It performs heart rhythm checks every 20 seconds, transmitting real-time results to the clinic's portal. Additionally, certain models within the Assert-IQ ICM family can be remotely programmed, allowing clinicians to adjust device settings, optimise performance, and limit unnecessary alerts or transmissions without requiring the patient to visit the clinic.


The device offers two battery life options, with a minimum duration of either three or six years, providing flexibility for diagnostic monitoring. The three-year option is suitable for traditional monitoring purposes, such as diagnosing fainting, heart palpitations, or abnormal heart rhythms. The six-year option is especially beneficial for long-term monitoring of individuals undergoing therapy, recent cardiac ablation procedures, or those at risk of developing further arrhythmias like atrial fibrillation. Advanced algorithms are incorporated to detect irregular heartbeats and provide clinically actionable data.


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