VeraLight, Inc. receives Health Canada license approval
Over the last year I’ve provided statistical consulting for VeraLight, Inc., a medical device company based in Albuquerque, NM. The SCOUT DS is the first non-invasive diabetes screening system designed to provide an accurate and convenient method for screening type 2 diabetes and pre-diabetes based on the presence of advanced glycation endproducts (AGEs) biomarkers found in skin. I have been primarily responsible for demographic subgroup analysis of pre-clinical trial data and review of the analysis plan for the FDA clinical trial. Today they announced that they have received Health Canada license approval:
ALBUQUERQUE, N.M., April 26, 2011 — 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.
… Scout DS is slated for market introduction later this year in Canada and select countries outside of the United States.
I’m really excited for them. I imagine this product making diabetes screening a 5-minute procedure at every pharmacy drug counter. I’m really proud of the work John, Ries, Ed, Jeff, and the rest of the group is doing to make this a reality.
JULY 28, 2011 – UPDATE
• VeraLight announces CE mark approval of the SCOUT DS® for non-invasive diabetes screening. So they’ve passed Canada and Europe!
AUGUST 25, 2011 – UPDATE
• VeraLight announces agreement with Pear Healthcare Solutions.
VeraLight and Pear Healthcare Solutions sign Canadian distribution agreement for SCOUT DS® Noninvasive Diabetes device.