CardioWise™ Receives US FDA 510(k) Clearance for Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) Heart Function Analysis Software
Summary
The software calculates a Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) value to highlight and color code motions of the heart wall. SQuEEZ is based on the ability in sequential high resolution cardiac CT scans to track movement of individual points on the endocardium during the contraction of the heart. Cardiac CT combined with SQuEEZ analysis software can provide clinicians with a normalized measurement to determine the answer to the first and most important clinical question a cardiac surgeon needs to know for patients with Cardiovascular Disease (CVD) symptoms—“Is the contractile function normal or not normal?” SQuEEZ allows the surgeon to make a more informed decision for the patient, whether it is a drug, surgery or medical device, and then follow the patient’s recovery and progress after the procedure, non-invasively and with extremely low exposure to radiation. SQuEEZ will bring extremely important new quantitative metrics to evaluate and treat patients with cardiovascular disease. CardioWise can now market the SQuEEZ analysis to provide give caregivers an easy-to-read, quantitative 4D color model that allows physicians to make better, more informed decisions about their patients’ care.” CardioWise™ is commercializing patented, non-invasive Cardiac CT analysis software that produces a quantified 4D image model of the human heart, called Stretch Quantifier for Endocardial Engraved Zones™ (SQuEEZ™).