CardioWise™ Receives ISO 13485:2016 Clearance for Design, Development, and Marketing of Software as a Medical Device (SaMD) For the Medical Device Industry
CardioWise, Inc., is pleased to announce that Perry Johnson Registrars, Incorporated has audited the CardioWise Quality Management System (QMS) and determined CardioWise is in conformance with ISO 13485:2016. Perry Johnson Registrars Certificate C2022-02910 was issued July 16, 2022, and represents the first step in the process of obtaining a CE mark and Medical Device Registration for the European Union (EU) that will allow CardioWise to market its products there.
This follows the company’s FDA 510(k) Clearance for CardioWise SQuEEZ that allows the company to commercialize its software in the US. SQuEEZ is based on the ability in high resolution cardiac CT scans to track points on the endocardium as they move during the contraction of the heart to allow quantitative assessment of regional myocardial heart wall motion. The analysis of four dimensional SQuEEZ parameters has the potential to improve the ability to quantify accurately the regional myocardial contractile function (ability of the heart to pump blood) through the heart muscle of the left ventricle.