IMDS Imaging Diagnostic Systems Receives FDA Export Certification
FORT LAUDERDALE, Fla., Sept. 25 /PRNewswire/ --
Imaging Diagnostic Systems, Inc. (OTC Bulletin Board: IMDS) announced today
that the Company has received export certification from the Food and Drug
Administration (FDA), pursuant to Section 802 of the Federal Food, Drug, and
Cosmetic Act. This Certificate enables IDSI to export the CTLM(R) to foreign
markets with the FDA's approval.
Imaging Diagnostic Systems has received CE Marking, UL listing, and
recently received ISO 9002 certification permitting the Company to market its
product internationally. The Company is seeking PreMarket Approval (PMA) from
the Food and Drug Administration (FDA) for its CTLM(R) system to be used as an
adjunct to mammography to aid in the detection of breast abnormalities. Under
the new Modular submission approach, the Company's PMA application has been
divided into different modules, each of which will contain documentation
required for the FDA review. The company has now submitted a total of four
modules and is currently completing the PMA application as the final
submission of the FDA approval process.
Imaging Diagnostic Systems, Inc. has developed the world's first patented
laser-based breast imaging system that utilizes state-of-the-art laser
technology and proprietary and patented algorithms to create three-dimensional
cross sectional images of the breast. The CTLM(R) is a non-invasive, painless
examination that does not expose the patient to radiation or require breast
compression.
In conjunction with the provisions of the Safe Harbor section of the
Private Securities Litigation Reform Act of 1995, this news release may
contain forward-looking statements pertaining to future anticipated projected
plans, performances and developments, as well as other statements relating
future operations. All such forward-looking statements are necessarily only
estimates of future results and there can be no assurance that actual results
will not materially differ from expectation. Further information on potential
factors that could affect Imaging Diagnostic Systems, Inc., is included in the
Company's filing with the Securities Exchange Commission.
Interested persons are encouraged to visit the Company's website
www.imds.com
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SOURCE Imaging Diagnostic Systems, Inc.
-0- 09/25/2001
/CONTACT: Margie Adelman, +1-561-620-7440, or Margie10@hotmail.com, for
Imaging Diagnostic Systems, Inc.; or Deborah O'Brien, VP Corporate
Communications of Imaging Diagnostic Systems, Inc., +1-954-581-9800/
/Web site: imds.com /
(IMDS)
CO: Imaging Diagnostic Systems, Inc.; Food and Drug Administration (FDA),
ST: Florida
IN: MTC OTC
SU:
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