Cardiac electrophysiology application software

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Class:

Class IIa

Manufactured by:

Cardiologs Technologies 100 rue Reaumur, Paris, 75002 France

Therapeutic area:

47699 - Cardiac electrophysiology application software

Therapeutic indications:

The Cardiologs Platform (also known as Cardiologs ECG Analysis Platform) is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in subjects over 18 years of age. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices for the assessment the heart rhythm. The Cardiologs Platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. The Cardiologs Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. The Cardiologs Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. Cardiologs Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician?s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

Authorization status:

A

Authorization date:

2022-01-06