In our premiere issue of Vein Therapy News, we brought you a feature on the VeinViewer, now the product has recieved worldwide recognition!

The VeinViewer – a vascular imaging system – allows physicians, nurses and other health care professionals to clearly see accessible vasculature (or lack thereof) in real time. The device uses a combination of near-infrared light and patented technologies to image vascular structures and project their location directly on the surface of the skin. This provides clinicians with a safe, non-invasive adjunct technology for clinical treatments and procedures including, but not limited to: IV insertions, PICC line insertions, routine venipuncture (blood sampling), blood and plasma donations and treatment for varicose and spider veins.

“The VeinViewer is changing the standard of compassionate care, and now with these new certifications, we are able to ship to Europe. Patients around the globe will have access to this leading-edge technology and all the benefits it allows,” said Mark Darty, executive vice president of operations at Luminetx. “This is a very special day for our team – the summation of tireless efforts and the judicious development of a quality program from ground up.”

The CE Marking is a manufacturer's declaration that demonstrates compliance with applicable European Directives – comparable to the U.S. Food and Drug Administration’s clearance process. For most products sold in the European market, the CE Marking and a declaration of conformity is mandatory. All such products must bear the CE Marking as a minimum base requirement for market entry.

Before getting certifications to affix the CE Mark on the VeinViewer, the Luminetx team first had to go through the process of getting the product’s ISO 13485 certification, which is the European medical device quality system standard. A significant portion of demonstrating compliance with the EU Directive requirements is the establishment and independent assessment of the quality system. After building its quality program, the Luminetx team then submitted that program for review to an outside auditing agency to verify compliance with the aforementioned European standard. Certifications granted for the VeinViewer are as follows: ISO 13485:2003; ISO 13485:2003 CMDR; and 93/42/EEC.

Pilot product manufacturing of the VeinViewer began in spring 2006, with its FDA clearance as a Class I Exempt Medical Device granted and full U.S. commercial roll-out following in the fall of 2006. Among the leading institutions where the more than 400 VeinViewers currently in use are Memphis-based Le Bonheur Children’s Medical Center and St. Jude Children's Research Hospital, Rainbow Babies & Children’s Hospital in Cleveland, University of Wisconsin Children’s Hospital, Brigham and Women's Hospital in Boston, SSM Cardinal Glennon Children's Medical Center in St. Louis, Anne Arundel Medical Center in Annapolis, Md., and Midwest Vein Center in the Chicago area, just to name a few.

By projecting real-time images of a patient's vasculature directly onto the skin, clinicians have the ability to visualize the location of the target area regardless of a patient’s age, body type or skin tone. During prototype development in December 2004, the device was recognized by Time magazine as “one of the most innovative medical inventions” of the year.

About Luminetx

Based in Memphis, Tenn., Luminetx Corporation discovers, develops and commercializes medical product and biometric technologies. Technology magazine Red Herring named Luminetx among its 2006 list of “Top 100 Companies in North America.” The company’s premier product, VeinViewer, is now available and in use nationwide. For more information on Luminetx and VeinViewer, visit www.luminetx.com .