The application, in significant part, required that Miraculins develop an ISO 13485 certified Quality Management System. Miraculins was issued its formal ISO Certificate of Registration by The BSI Group Inc. on January 13, 2012.
"Receiving Health Canada clearance for the PreVu Non-Invasive Skin Cholesterol POC test will allow us to begin selling this important new screening tool in Canada to more effectively help detect the hidden risk of coronary artery disease", said Christopher J. Moreau, President & CEO of Miraculins. "We have significantly advanced discussions with distribution partners in a number of market segments and I look forward to updating the market on PreVu launch plans in the near term."
About the PreVu Non-Invasive Skin Cholesterol Test
PreVu is a non-invasive risk assessment technology that evaluates the additional risk a person may have for coronary artery disease (CAD) by conveniently and painlessly testing their skin cholesterol level. High levels of skin cholesterol have been shown to be correlated to CAD as measured by stress test, angiography, coronary calcium, and carotid intima-media thickness, inflammatory markers of vascular disease, previous heart attack incidents and Framingham risk score.