Tag: FDA clearance
Two innovative ECG monitors obtain new US FDA clearances
Two innovative electrocardiogram (ECG) products have gained new US Food and Drug Administration (FDA) clearances for monitoring cardiac arrhythmias—Fourth Frontier’s Frontier X Plus (FX+)...
HeartKey Rhythm suite launched following US FDA clearance
B-Secur has announced the US Food and Drug Administration (FDA) clearance and launch of HeartKey Rhythm—a suite of electrocardiogram (ECG) algorithms and analytics designed...
Biotronik receives FDA clearance on BioMonitor III
Biotronik has announced FDA clearance of the BioMonitor III injectable cardiac monitor (ICM). BioMonitor III is designed to document suspected arrhythmia or unexplained syncope...