Device Dossier

Cardiac electrophysiology application software

Device Dossier for Cardiac electrophysiology application software (Cardiac electrophysiology application software, Class IIb, sponsor MDG). ARTG record,…

Intended purpose

Cloud-based software for the assessment of cardiac arrhythmias using a single- or two-lead ECG data from adult patients. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result.

TGA Public Summary