WINNIPEG, Manitoba – December 23, 2013 - Miraculins Inc.(TSX-V:MOM), (”Miraculins” or the “Company”) a medical diagnostic company focused on acquiring, developing and commercializing diagnostic and risk assessment technologies for unmet clinical needs, is pleased to announce today that it has filed pre-submission documentation with the USFDA (United States Food and Drug Administration) for its Scout DS® System towards securing its ultimate marketing clearance in the United States.
The Scout DS® is the world’s first non-invasive and highly-sensitive test designed to measure diabetes related biomarkers in the skin. It does not require a blood draw or fasting and generates a result in as little as 80 seconds. The Scout DS® uses visible light to measure the optical signature of fluorescent biomarkers in the skin, the accumulation of which are accelerated by abnormal blood sugar levels and oxidative stress.
The pre-submission documentation filing is the first formal step by Miraculins in establishing a clinical and regulatory plan for the regulatory clearance of theScout DS® in the United States. Based on feedback from this cooperative process with the FDA, Miraculins will develop appropriate study protocols in support of FDA marketing clearance.
Click here for the article