CardioWise Receives US FDA 510(k) Clearance for Heart Function Analysis Software


CardioWise, Inc., is pleased to announce Clearance of its 510(k) application by the US Food and Drug Administration (FDA) for its heart function analysis software, Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ).

Fayetteville, AR - The 510(k) premarket notification letter indicates that the FDA has determined that SQuEEZ may be legally marketed in interstate commerce according to its indications for use. SQuEEZ is an image analysis software application for cardiac Computer Tomography (CT) studies to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The software calculates a Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) value to highlight and color code motions of the heart wall. Additional tools are provided to display regional motion properties of the heart.

SQuEEZSQuEEZ 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. The analysis of SQuEEZ parameters has the potential to improve the ability to quantify accurately the ability of the heart to pump blood through the left ventricle. 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. The software provides an intuitive method to classify LV contractile function that can provide significant improvement in clinical decision-making relative to the inconsistent, qualitative tests used today. The software quantifies and localizes left ventricular (LV) contractile dysfunction which will improve clinical outcomes by addressing imitations of the current nonquantitative metrics of regional LV function. The simplicity of interpreting and displaying these results will increase patients’ understanding of their coronary artery disease.

Jack Coats, CEO of CardioWise, Inc. said, “We are very pleased that the 510(k) application for SQuEEZ has been cleared for commercial use in the US. I congratulate the CardioWise Engineering team, led by Geoffrey Dalbow, Chief Technology Officer for its efforts over the past three years to develop the technology that was licensed from Johns Hopkins Medicine. 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™). CardioWise heart analysis software combined with cardiac CT is a single diagnostic test that is able to provide quantitative analysis of the myocardium, arteries and valves with an unprecedented level of detail. It has the opportunity to become the new gold standard of care for heart health analysis. CardioWise™ is a VIC Technology Venture Development portfolio company.