Flying Brands, based in Jersey, United Kingdom, announced that it has received a CE (Conformité Européene) mark approving its Stone Checker software for use in the European Union and some affiliated nations in Europe. The CE seal confirms that a product meets the essential requirements of relevant European health, safety, and environmental protection legislation.
Flying Brands is an investment company that focuses on opportunities in the technology and logistics sectors, and Stone Checker Software Ltd, is part of Flying Brands.
Stone Checker software provides details about kidney stones to aid in clinical decision-making. The semi-automated kidney stone assessment tool generates metrics for physicians that use a patient’s non-contrast CT scans.
CT Texture Analysis (CTTA) metrics of Stone Checker showed that it reflected stone characteristics and composition, and predicted ease of shock-wave lithotripsy fragmentation in studies.
The strongest correlation with number of shocks required to fragment the stone was mean Hounsfield unit and a CTTA metric that measured the entropy of the pixel distribution of the stone image. Image entropy is a quantity used to describe how “busy” an image is, i.e., the amount of information that must be coded for by a compression algorithm.
Using multiple linear regression analysis, the best model showed that CTTA metrics of entropy and the sharpness of the peak of the frequency distribution curve could predict 92% of the outcome of number of shocks needed to fragment the stone. This method was superior to using stone volume or density as a predictive measure, according to the company.
The company’s next goal is for Stone Checker to earn FDA approval in 2018.