The CE mark approval is based on safety and effectiveness studies on a cohort of 738 study subjects.
Scout DS is used to noninvasively screen individuals of 18 years or older who are at risk for prediabetes and/or type 2 diabetes to assess whether diagnostic testing is necessary.
Scout DS measures skin fluorescence using proprietary technology to detect biological markers found in skin related to cumulative glycemic exposure, oxidative stress and microvascular changes.
It uses a proprietary algorithm which adjusts variations in skin tone and transforms the measured skin fluorescence and reflectance into a Scout Diabetes Score.
VeraLight plans for an FDA filing in 2012.
