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Sectra Receives FDA Clearance FOR MicroDose Mammography Modality

May 4, 2011

SHELTON, Connecticut, May 4, 2011 /PRNewswire/ — Women in the U.S. will
now have the same opportunity as millions of European women already haveӚ­; to
undergo mammography with a significantly lower radiation dose. This is the
result of the U.S. Food and Drug Administration’s (FDA) clearance of the
Swedish IT and medical technology company Sectra’s digital mammography
system, Sectra MicroDose Mammography(TM)
(http://www.sectra.com/pr-microdose). Achieving best-in-class cancer
detection (http://www.sectra.com/pr-symposium), the Sectra MicroDose photon
counting (http://www.sectra.com/pr-photon-counting) technology reduces the
radiation dose by half of that used by other digital or film-based systems.

    (Photo: http://www.newscom.com/cgi-bin/prnh/20110504/453829 )

    (Photo: http://www.newscom.com/cgi-bin/prnh/20110307/441548 )

“The advantages of a yearly mammography examination clearly outweigh the
risks. But a woman undergoing regular mammography examinations is exposed to
radiation every time she is screened, and so it is important to minimize
radiation dose,” says Stamatia Destounis, MD, managing partner, Elizabeth
Wende Breast Care, LLC.

Sectra MicroDose has already been contributing to a significant reduction
of radiation dose in most major European mammography screening programs. It
has been used for more than seven years and is operational in countries
throughout Europe, Australia, New Zealand and Japan. Recently, the system was
also approved in Canada and Russia.

“Until now, digital mammography systems have managed to reduce the
radiation dose slightly below those of film-based systems,” says Dr. Jesper
Soderqvist
, president of Sectra’s mammography operations. “Sectra MicroDose
enables mammography service providers to reduce the radiation dose by half,
which is a significant benefit to women,” adds Dr. Soderqvist.

Key to the very high image quality at significantly reduced radiation
dose, is Sectra’s revolutionary photon counting detector technology. Sectra
MicroDose is the first imaging modality based on photon counting detector
technology to receive FDA clearance.

Improving cancer detection with photon counting technology

Sectra MicroDose Mammography is based on the company’s proprietary photon
counting technology. A multi-vendor comparison study (
http://www.sectra.com/pr-symposium) presented at a European radiology
congress in March 2011 indicates better cancer detection for Sectra MicroDose
compared to other mammography systems available in the U.S.

“Ongoing research shows great promise for further improvements in breast
cancer detection with our unique photon counting technology,” explains Dr.
Soderqvist. “Our technology is also the cornerstone in a large European
research project for developing and evaluating new revolutionary breast
cancer detection methods,” adds Dr. Soderqvist.

Unlike traditional analog and digital mammography modalities, which
require a higher dose of radiation to ensure image quality; Sectra MicroDose
Mammography detects x-ray photons individually. Thereby the Sectra MicroDose
detector makes it possible to reduce the radiation dose by half from that
used by other digital or film based systems, while still obtaining as high or
higher image quality. Images are delivered with 25 megapixles, which is two
to four times higher resolution than that of other digital systems. The high
resolution of the images aids detection of early changes that occur with
breast cancer.

About Sectra

Sectra develops and sells IT systems and products for radiology,
mammography and orthopedics. More than 1,100 hospitals, clinics and imaging
centers worldwide use the systems daily, together performing over 52 million
radiology examinations annually. This makes Sectra one of the world-leading
companies within systems for handling digital radiology images. In
Scandinavia, Sectra is the market leader with more than 50% of all film-free
installations. Sectra’s systems have been installed in North America,
Scandinavia and most major countries in Europe and the Far East.

Sectra was founded in 1978 and has its roots in Linkoping University in
Sweden. The company’s business operation includes cutting-edge products and
services within the niche segments of medical systems and secure
communication systems. Sectra has offices in 12 countries and operates
through partners worldwide. Sales in the 2009/2010 fiscal year totaled SEK
848 million
. The Sectra share is quoted on the NASDAQ OMX Stockholm AB
exchange. For more information, visit http://www.sectra.com

Press releases, images and background information are available at
http://www.sectra.com/medical/press

    Contact: Mikael Anden, President
    Sectra North America
    E-mail: Mikael.Anden@sectra.se
    Phone: +1-203-925-0899 ext. 253

http://www.sectra.com/medical

SOURCE Sectra Mamea AB


Source: newswire



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