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FDA provides PMA approval for Spectrascience's WavSTAT technology enhancements

Published on September 17, 2009 at 2:46 AM · No Comments

SpectraScience, Inc. (OTC Bulletin Board: SCIE), a San Diego based medical device company, today announced that its application for premarket approval (PMA) relating to key enhancements of its WavSTAT platform technology has been approved by the Food and Drug Administration. The Company can now begin commercial distribution of the enhanced WavSTAT technology.

Jim Hitchin, SpectraScience's' CEO said, "We are pleased to now be able to bring to market the most up-to-date, leading edge technology for use in cancer screening. The enhancements we have made to the WavSTAT will make it easier for physicians to use and will provide an even greater level of critical data in a screening environment."

SpectraScience has filed for 60 patents worldwide on its WavSTAT Optical Biopsy and LUMA(R) Cervical Cancer Imaging Systems that are used to diagnose tissue to determine within seconds if it is normal, pre-cancerous, or cancerous. The WavSTAT and LUMA Systems are currently approved by the FDA for detecting pre-cancer and cancer in the colon and cervix, and an evaluation for detection of pre-cancers in the throat ("Barrett's esophagus") is being tested.

Source: http://www.spectrascience.com

Posted in: Device / Technology News | Medical Condition News

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