Device Category Dossier

Cardiac electrophysiology application software

Device Category Dossier for Cardiac electrophysiology application software. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Cardiac electrophysiology application software derives, displays, processes and provides automated interpretation of electrocardiogram (ECG) data acquired from single-lead, multi-lead or Holter monitoring devices, using algorithms to detect cardiac rhythms and abnormalities from electrical signals of the heart. These applications are intended for use by qualified healthcare professionals to assess arrhythmias and structural heart abnormalities in adult and paediatric patient populations.