Imaging
Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS), a pioneer in laser
optical breast imaging systems, announced that CT Laser Mammography
technology will be represented at the "Progress in Diagnostics of Breast
Cancer" Symposium in Szczawnica, Poland, January 4-6, 2007. The symposium
will focus on state-of- the-art devices for medical imaging of the breast
and standards for biopsy, among other topics.
The symposium is organized by the Krakow Branch of the Maria
Sklodowska- Curie Memorial Institute of Oncology in conjunction with the
Krakow Foundation for the Oncology Surgery Clinic.
Imaging Diagnostic Systems will exhibit clinical cases from global user
sites and will feature a presentation of the CT Laser Mammography system's
unique breast cancer detection capabilities. IDSI is represented in Poland
by its exclusive distributor, EDO MED, of Warsaw, Poland and has operating
systems at the Regional Center of Oncology, Bydgoszcz, Poland, and the
Gliwice branch of the Maria Sklodowska-Curie Memorial Institute of
Oncology, Gliwice, Poland, under clinical collaboration agreements.
"We are pleased to have CTLM technology featured at the symposium, as
it is targeted to oncology centers in Poland who handle the bulk of breast
cancer screening, diagnostic work-ups, and treatment follow-up with various
imaging devices. We see a growing interest in CTLM from oncology centers
not only in Poland but globally, based on our results. In December, IDSI
released work- in-process results from Catholic University in Rome,
comparing the sensitivity of CTLM to MRI in following angiogenesis response
to chemotherapy; CTLM had better sensitivity in these cases," stated
Deborah O'Brien, IDSI's Senior Vice President.
The CTLM(R) system is a new continuous wave laser breast imaging system
that utilizes state-of-the-art technology and patented algorithms to create
3-D images of the breast. The procedure is non-invasive, painless, and does
not expose the patient to radiation or require breast compression. In the
United States, Imaging Diagnostic Systems is seeking FDA Premarket Approval
(PMA) for the Computed Tomography Laser Mammography (CTLM(R)) system to be
used as an adjunct to mammography. The FDA has determined that the
Company's clinical investigation is a non-significant risk (NSR)
investigational device study because it does not meet the definition of a
significant risk (SR) device under 812.3(m) of the investigational device
exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by
United States Federal Law to investigational use only in the United States.
The Imaging Diagnostic Systems CTLM system has received other registrations
including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO
13485:2003 and FDA export certification.
As contemplated by 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, or
projected plans, performances and developments, as well as other statements
relating to future operations. All such forward-looking statements are
necessarily only estimates or predictions of future results or events and
there can be no assurance that actual results or events will not materially
differ from expectations. Further information on potential factors that
could affect Imaging Diagnostic Systems, Inc., is included in the Company's
filings with the Securities and Exchange Commission. We expressly disclaim
any intent or obligation to update any forward-looking statements.
Imaging Diagnostic Systems, Inc.
imds/
Комментариев нет:
Отправить комментарий