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.
Chet Sievert, SpectraScience chairman and CEO, said, "We are extremely delighted that the FDA was so prompt in reviewing and approving our next-generation Optical Biopsy System, WavSTAT II. WavSTAT II incorporates features and enhancements recommended by our clinical partners over the course of the ongoing cost-effectiveness and clinical outcome studies performed with the first-generation system. The company believes WavSTAT II simply is a smaller, more user-friendly system."