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VeraLight Announces FDA Licence Approval of the Scout DS(R) for Non-Invasive Diabetes Screening


4/26/2011 6:26:54 AM

ALBUQUERQUE, N.M., April 26, 2011 /PRNewswire/ -- VeraLight Inc., a privately held medical device company, based here, today announced its Scout DS® Device was granted a Health Canada Medical Device Licence for non-invasive diabetes screening. The easy to operate device needs no blood and does not require fasting. The patient simply places their forearm onto the portable table-top unit and a quantitative result is reported in about three minutes.

"I am excited about this groundbreaking non-invasive technology," said Tom Smiley, BScPhm, PharmD from Pharmavision Health. "Given its convenience and sensitivity, Scout DS is ideal for early diabetes detection and pharmacies would be excellent screening locations." Data from 424 patients in the Health Canada filing show Scout DS identified 33% more people with impaired glucose tolerance or type 2 diabetes vs. fasting plasma glucose and 9% more than hemoglobin A1c. Scout DS is indicated for non-invasive screening of individuals 18 years or older who are at risk for pre-diabetes (impaired glucose tolerance) or type 2 diabetes to determine whether diagnostic testing is necessary.

Scout DS measures skin fluorescence using proprietary technology to detect abnormal concentrations of advanced glycation endproducts (AGEs) which are diabetes-related biological markers found in skin. Previous studies have shown the presence of skin AGEs correlate well with diabetes and are a predictor of the disease's serious complications. Analogous to a "diabetes odometer," AGEs are a sensitive metric for the cumulative damage the body has endured due to the effects of abnormally high blood sugar and oxidative stress.

The Health Canada Medical Device Licence is proof of conformity that certifies the product meets Canadian safety, health, and environmental requirements. Scout DS is slated for market introduction later this year in Canada and select countries outside of the United States.

About VeraLight

VeraLight is a privately held medical instrumentation company that was established in 2004 to focus on non-invasive diabetes screening. The company's mission is to help stem the tide of the global diabetes epidemic through early detection of the more than 500 million individuals who have undiagnosed diabetes or impaired glucose tolerance, thus enabling initiation of therapies that can prevent diabetes or reduce its complications and associated costs. For more information and product video see http://www.veralight.com.

Contact Janet Garcia VeraLight 505/272-7023 janet.garcia@veralight.com


Read at BioSpace.com


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