Sectra applies for US approval of low-dose mammography

Sectra applies for US approval of low-dose mammography

The IT and medical-technology company Sectra has submitted the first part of its
application to sell Sectra MicroDose Mammography, the company's mammography
system with the lowest radiation dose in the world, in the US.

The US has the world's largest mammography market and the transition to digital
technology has recently commenced. For medical-technology products to be
marketed and sold in the US, approval from the FDA (Food and Drug
Administration) in the United States is required.

“Once the approval of the FDA is received, Sectra MicroDose Mammography can be
sold to mammography clinics in the American market,”, says Jesper Söderqvist,
President of Sectra Mamea AB.  “Our main competitive edge in this important
market comprises our experience of Scandinavian mammography and the fact that
our system generates the world's lowest radiation dose, which we believe
American women will appreciate.”

The application procedure that has now been initiated by Sectra is modular, and
the application has been expanded to include the latest version of Sectra
MicroDose Mammography.

Safe and effective mammography screening 
With retained or superior imaging quality, Sectra's mammography system, Sectra
MicroDose Mammography, generates by far the lowest dose of radiation among all
of the systems offered on the market. The lowest dose of radiation in
combination with good ergonomics and a well-conceived workflow enables
mammography nurses and radiologists to work more efficiently and safely. At the
same time, the radiation to which the women are exposed is minimized to the
lowest conceivable level. Sectra MicroDose Mammography is based on unique
detector technology that counts every X-ray photon. This technology is
considered by many to be the X-ray technology of the future.


Dr. Torbjörn Kronander, President, Sectra Imtec AB, +46 705 23 52 27 
Dr. Jan-Olof Brüer, CEO and President, Sectra AB, +46 13 23 52 09


About Sectra's medical operations
Sectra is one of the world's major diagnostic imaging system (PACS) providers.
More than 900 hospitals worldwide use the system daily and more than 40 million
radiology examinations are diagnosed in Sectra's system annually. In
Scandinavia, Sectra is the market leader with more than 50% of all film-free
installations. Outside Scandinavia, Sectra's system is installed at customers in
North America and most major countries in Europe and the Far East.

About the Sectra Group
Sectra successfully develops and sells cutting-edge products in the expansive
niche segments of medical systems and secure communication systems.  The company
was founded in 1978 and has its roots in the Linköping Institute of Technology
in Sweden.  Today, Sectra has offices in eleven countries and operates through
partners worldwide.  . Sales in the 2006/2007 fiscal year totaled SEK 673
million. The Sectra share is quoted on the Nordic Exchange in Stockholm. For
more information about Sectra visit http://www.sectra.com.