FDA clearance for Assert-IQ insertable cardiac monitor to help doctors monitor heart rhythms long-term.- Abbott

This clearance builds on Abbott's portfolio of connected health devices that can better help doctors manage and treat their patients remotely.

While many commercially available ICMs monitor a person's heart rhythms for a few years, Assert-IQ offers two options with a battery life of at least three or six years to provide doctors a new level of flexibility in diagnostic monitoring . While the three-year option may be preferred for more traditional monitoring, such as diagnosing fainting, heart palpitations or detections of abnormal heart rhythms, an option offering at least six years of battery life empowers physicians to monitor long-term. This monitoring can be especially important when caring for people who are undergoing therapy, have recently had a cardiac ablation procedure or who are at risk of developing further arrhythmias such as atrial fibrillation. In both options, advanced algorithms are available to detect irregular heartbeats and provide clinically actionable data.

Using Bluetooth technology, Abbott's Assert-IQ ICM is designed to remain connected to a transmitter – usually the person's own cell phone – where it checks heart rhythms every 20 seconds, transmitting results in real-time to the clinic's portal. Additionally, some models of the Assert-IQ ICM family can be remotely programmed allowing the clinician to adjust the settings of the connected device, optimize performance and limit unnecessary alerts or transmissions – all without requiring the patient to visit the clinic. The Assert-IQ ICM also offers advanced diagnostic capabilities to provide physicians with more clinically relevant information about the cardiovascular health of the patient, allowing care providers to make clinical decisions faster.