Norcross-based SpectRx Inc. announced that  U.S. clinical trials will be held prior to submission to the Food and Drug Administration (FDA) of  BiliCheck, the first commercially available hand-held, non-invasive bilirubin analyzer for infants which was widely acclaimed at the Medica 97 trade show in Dusseldorf, Germany last week.

      Bilicheck uses light to measure bilirubin levels in newborn patients without a blood sample.  Excessive bilirubin causes jaundice which affects approximately 50% of newborns.

      According to a SpectRx news release, more than 350 medical equipment distributors from 64 countries attending Medica applied to market Bilicheck in their respective markets.  Medica is the largest medical trade show in the world with more than 100,000 medical professionals attending.

      Bilicheck may not be sold in the U.S. without FDA approval.  Healthdyne Technologies holds U.S. marketing rights for the product and will be responsible for the U.S. clinical trials.

      “The numerous meetings and discussions offer the promise of a rapid expansion of global distribution,” said Keith Ignotz, SpectRx chief operating officer.  “Acceptance of the product was high…”

      SpectRx is a medical technology development company that specializes in less and non-invasive alternatives to existing blood tests and medical diagnostic and monitoring procedures.

      For more information, call Bill Wells or Thomas Muller at (770) 242-8723.