From YAHOO News:
NORCROSS, Ga., June 29 /PRNewswire/ -- SpectRx, Inc. (Nasdaq: SPRX - news) today announced it has received regulatory approval necessary to market the BiliCheck(TM) Non-Invasive Bilirubin Analyzer in Canada. The BiliCheck(TM) also conforms to the Underwriter's Laboratories (UL) standard for medical electrical equipment. The BiliCheck(TM) hand-held, painless, non-invasive bilirubin analyzer is designed to replace the common and painful heel stick blood test for infant jaundice.
Conforming to the Canadian Standards Association (CSA) medical electrical standards supports marketing partner Respironics' efforts to launch the BiliCheck(TM) in Canada. BiliCheck(TM) marketing activities in Canada are to begin as soon as practical following the preparation of marketing materials and shipment of product to Respironics. In support of a U.S. launch of the BiliCheck(TM), a 510(k) application is currently being prepared and the company anticipates a filing with the FDA during the summer.
''We are pleased with our progress in marketing the BiliCheck since worldwide sales began in earnest during May,'' said SpectRx President and CEO Mark A. Samuels. ''After initial shipments began on April 6, 1998, the majority of our international distributors completed required certification training, received their stocking inventory, and began the demonstration and evaluation process with end users by mid May. Distributors are currently marketing the product in 35
countries in Europe, Africa, South America and Asia/Pacific.''
The SpectRx BiliCheck(TM) Non-Invasive Bilirubin Analyzer tests for Infant Jaundice by shining, collecting and analyzing light from the infant's forehead. The BiliCheck(TM) provides immediate and clinically meaningful results, regardless of the baby's skin color, gestational age or post-natal age. BiliCal(TM) Individual Calibration Tips are used with the BiliCheck(TM) to perform automatic calibration prior to each measurement ensuring accuracy comparable to the traditional blood test and to provide a clean surface for each baby tested to reduce the risk of cross-infection.
SpectRx is a developer and manufacturer of painless and bloodless medical products offering alternatives to traditional blood-based screening, diagnostics and monitoring tests. Other products under development by SpectRx are a non-invasive diabetes screening device with Roche Diagnostics BMC and a painless, bloodless glucose meter with Abbott Laboratories [NYSE:ABT - news].
Certain matters discussed in this announcement contain forward-looking statements that involve material risks to, and uncertainties in the company's business which may cause actual results to differ materially from those anticipated by the statements made herein. The matters discussed herein should be viewed together with the Risk Factors in the Company's 10K for the year ending December 31, 1997 on file with the SEC.
SOURCE: SpectRx, Inc. |
