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Most recent entries
SpectraScience Provides Corporate Update and Outlook
SpectraScience appoints Sheldon L. Miller Esq. to its Board of Directors
SpectraScience Receives Notification of Pending Issuance of Two Patents
SpectraScience Retains Quorum Consulting
SpectraScience to Exhibit at Digestive Disease Week in New Orleans
SpectraScience Has Second Unannounced Inspection by FDA
SpectraScience’s Jim Hitchin Featured in MDDI Magazine Article
Health Radio - Interview with CEO, Jim Hichin
Professor Andreas Stallmach Chooses WavSTAT(R) Optical Biopsy System for Early Cancer Detection
SpectraScience CEO Jim Hitchin Speaks to Blogtalkradio About Better Cancer Screening Diagnostics
SpectraScience, Inc. Selects CWR & Partners as Its Public Relations Agency of Record
SpectraScience Forms Advisory Board - Governor Tommy Thompson to be Chairman
SpectraScience Releases Shareholder Newsletter
SpectraScience Engages European Contract Research Organization to Manage Clinical Trials
SpectraScience Awarded Japanese Patent 4361683 for Its Optical Biopsy Forceps System
News
SpectraScience’s Jim Hitchin Featured in MDDI Magazine Article
Mar 10, 2010
SAN DIEGO, March 10 /PRNewswire-FirstCall/-- SpectraScience, Inc. (OTC Bulletin Board:SCIE.ob - News), a San Diego based medical devicecompany, announced that its CEO, Jim Hitchin, was recentlyfeatured in an MDDI Magazine article entitled, "Fixing the 510(k) Process:Overhaul Would Be Overkill", reporting on inconsistencies in the 510(k)process which have led the FDA to consider overhaul.
Keypoints made by Hitchin in the article, were that:
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.
To read the MDDI article in its entirety, go to: http://www.mddionline.com/print/6871.
This news release contains forward-looking statements within the meaning of Section27A of the Securities Act of 1933, as amended, and Section 21E of theSecurities Exchange Act of 1934, as amended. These forward-looking statementsinvolve risks and uncertainties that may cause SpectraScience's actual resultsto differ materially from results discussed in forward-looking statements.Readers are urged to carefully review and consider the various disclosures madeby SpectraScience in this news release, its most recent Form 10-K and inSpectraScience's other reports filed with the Securities and ExchangeCommission ("SEC") that attempt to advise interested parties of therisks and factors that may affect SpectraScience's business. Theseforward-looking statements are qualified in their entirety by the cautions andrisk factors filed by SpectraScience in its annual report on Form 10-K andother documents.
AboutSpectraScience, Inc.
SpectraScienceis a San Diego based medical device company that designs,develops, manufactures and markets spectrophotometry systems capable ofdetermining whether tissue is normal, pre-cancerous or cancerous withoutphysically removing tissue from the body. The WavSTAT Optical Biopsy Systemuses light to optically scan tissue and provide the physician with an immediateanalysis. With FDA approval for sale in the U.S. and the CE Mark for the EuropeanUnion, the WavSTAT System is the first commercially available product thatincorporates this innovative technology for clinical use. The Company's LUMAimaging technology has received FDA approval for an optical non-invasive systemthat is proven to more effectively detect cervical cancer precursors thanconventional methods available in the market today.
Contact:
SpectraScience, Inc.
Jim Hitchin, Chief Executive Officer
(858) 847-0200 x201
Hayden Communications - Investor Relations
Todd Pitcher
(858) 518-1387