Biotronik gets FDA nod for cardiac monitor

Biomedical device company Biotronik has received U.S. Food and Drug Administration (FDA) approval for its BioMonitor 2 insertable cardiac monitor with ProMRI technology.

Designed to aid physicians in detecting and diagnosing atrial fibrillation, ventricular tachycardia and fibrillation, and syncope, BioMonitor 2 is compatible with full-body 1.5- and 3-tesla MR scans, according to the vendor. BioMonitor 2 can also be used to monitor atrial events in patients who have undergone ablation procedures, Biotronik said.

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