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Cardiologs ECG Analysis Platform receives FDA clearance

Press releases may be edited for formatting or style | July 06, 2017 Cardiology

Scientific Validation of Cardiologs. When defining the reliability of diagnosing AFib and other arrhythmias, the term Positive Predictive Value (PPV) refers to the percentage of true positive cases among total cases detected. Conventional “state-of-the-art” PPV for detecting AFib is less than 59%1. The PPV for Cardiologs’ detection of AFib was 91%2 included in the cleared FDA submission. In addition, also as included in the cleared FDA submission, Cardiologs’ sensitivity for detecting AFib was reported to be 97%3 (the percentage of positive cases truly identified) and was superior to “state-of-the-art” conventional methods of detecting AFib and other arrhythmias. Cardiologs’ study results have been published in the European Journal of Preventive Cardiology (2016, Vol. 23(2S 41-55). The study’s investigators concluded: “This (Cardiologs) method may be more reliable and accurate than previous methods in the diagnosis of AFib on long-duration ambulatory ECG and other monitoring devices.”

About Cardiologs Technologies SAS
Headquartered in Paris, Cardiologs Technologies is a privately held company offering the “Cardiologs ECG Analysis” platform to aid cardiologists in screening for arrhythmias such as AFib using long-duration ambulatory ECG monitoring recordings.
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1 Source: European Journal of Preventive Cardiology (2016, Vol. 23(2S 41-55).
2 Duration PPV results from testing following the recognized consensus standards ANSI/AAMI EC57:2012 and IEC 60601-2-47:2012 on MIT-BIH database.
3 Duration Sensitivity results from testing following the recognized consensus standards ANSI/AAMI EC57:2012 and IEC 60601-2-47:2012 on MIT-BIH database.

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