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Key points made by Hitchin in the article, were that:
To read the MDDI article in its entirety, go to: http://www.mddionline.com/print/6871.
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This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements involve risks and uncertainties that may cause SpectraScience's actual results to differ materially from results discussed in forward-looking statements. Readers are urged to carefully review and consider the various disclosures made by SpectraScience in this news release, its most recent Form 10-K and in SpectraScience's other reports filed with the Securities and Exchange Commission ("SEC") that attempt to advise interested parties of the risks and factors that may affect SpectraScience's business. These forward-looking statements are qualified in their entirety by the cautions and risk factors filed by SpectraScience in its annual report on Form 10-K and other documents.
About SpectraScience, Inc.
SpectraScience is a San Diego based medical device company that designs, develops, manufactures and markets spectrophotometry systems capable of determining whether tissue is normal, pre-cancerous or cancerous without physically removing tissue from the body. The WavSTAT Optical Biopsy System uses light to optically scan tissue and provide the physician with an immediate analysis. With FDA approval for sale in the U.S. and the CE Mark for the European Union, the WavSTAT System is the first commercially available product that incorporates this innovative technology for clinical use. The Company's LUMA imaging technology has received FDA approval for an optical non-invasive system that is proven to more effectively detect cervical cancer precursors than conventional methods available in the market today.
-- With respect to the standard of equivalence, If the sponsoring company meets this criterion, or does it somewhat better, and the company demonstrates that there are no new and significant questions of safety or effectiveness, the American public is best served by accelerating new products to the market. -- The industry should work with the FDA to address any parts of the 510(k) process that aren't working the way they were intended to work. For example, Hitchin said that there needs to be improvements to address the inconsistencies between branches and between reviewer. -- The main problem he sees with the process is that submission requirements are a moving target--not only within the branches but also between reviewers and between the branches. Rather than a problem with the process, he suggests that many of the latest problems are the result of "a management problem that has been endemic at FDA since the Medical Device Amendments.
SOURCE SpectraScience, Inc.
