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Edmund Optics - Manufacturing Services 8/24 LB

SpectraScience Wins Approval for Optical Biopsy System

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MINNEAPOLIS & ST. PAUL, Minn., Dec. 5 -- SpectraScience Inc. said the US Food and Drug Administration (FDA) has notified the company that its second-generation WavSTAT II Optical Biopsy System has been approved for clearance to market. SpectraScience submitted a supplement to the original premarket approval application (PMA) of the WavSTAT I Optical Biopsy System and was granted an expedited "real-time review" by the FDA. The clinical and medical indications for WavSTAT II are the same that were granted for WavSTAT I for use as an aid to physicians for endoscopic colorectal cancer screening....Read full article

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    Published: December 2001
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