FDA approves BioMonitor 2 insertable cardiac remote monitor to treat arrhythmias- Biotronik
Biotronik, a leader in cardio- and endovascular medical technology,has announced FDA approval of BioMonitor 2, an insertable cardiac remote monitor with ProMRI technology. BioMonitor 2 is designed to provide physicians with the ability to accurately detect and diagnose atrial fibrillation, ventricular tachycardia and fibrillation, and syncope. The device can also be used to monitor atrial events in patients who have undergone ablation procedures.
A recent Australian pilot study showed greater than 90 percent transmission reliability for daily Biotronik Home Monitoring transmissions, exceeding proven patient compliance. In addition, BioMonitor 2 has a capacity of more than 60 minutes of electrocardiogram (ECG) recording time and Intelligent Memory Management ensuring that the most relevant events are always available for review. BioMonitor 2 can transmit up to six subcutaneous ECGs daily via Biotronik Home Monitoring.
Comment: The BioMonitor 2 received CE mark in August 2015.