Cardiovascular interpretive screening software

Definition

An interpretive software program intended to be used in the assessment of risk/probability for having a cardiovascular condition (e.g., significant coronary stenosis) or event (e.g., heart attack, ischemic stroke, unstable angina, coronary revascularization). It typically combines some of the following data: patient demographics, physical measurements, symptoms, medical history, results of the qualitative/quantitative clinical specimen in vitro diagnostic (IVD) tests. It typically creates a risk score or probability that may be used to guide patient management. It is not intended to produce risk scores for renal disease; this software is not an IVD device.

GUDID devices

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Last updated

2024-11-26 18:43:58