Device Dossier

Cardiac electrophysiology application software

Device Dossier for Cardiac electrophysiology application software (Cardiac electrophysiology application software, Class IIb, sponsor Elevate Medtech).…

Intended purpose

Software that uses deep learning algorithms to analyze ECG images or waveform data to assist in the diagnosis of arrhythmias and provide risk scores for cardiac dysfunction, thereby assisting physicians in their diagnostic decision-making.

TGA Public Summary