SpectraScience's Jim Hitchin Featured in MDDI Magazine Article
10 Mars 2010 - 3:09PM
PR Newswire (US)
SAN DIEGO, March 10 /PRNewswire-FirstCall/ -- SpectraScience, Inc.
(OTC Bulletin Board: SCIE), a San Diego based medical device
company, announced that its CEO, Jim Hitchin, was recently featured
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. Key
points 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
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. Contact:
SpectraScience, Inc. Hayden Communications Jim Hitchin, Chief
Executive Officer Investor Relations (858) 847-0200 x201 Todd
Pitcher (858)-518-1387 DATASOURCE: SpectraScience, Inc. CONTACT:
Jim Hitchin, Chief Executive Officer of SpectraScience,
Inc.,+1-858-847-0200, ext. 201; or Investor Relations, Todd Pitcher
of HaydenCommunications, +1-858-518-1387, for SpectraScience Web
Site: http://www.mddionline.com/print/6871
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