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Sectra receives FDA clearance for MicroDose Mammography modality

First-of-its-kind technology enables women to benefit from significant reduction of radiation exposure Women in the US will now have the same opportunity as million of European women already have; to undergo mammography with significantly lower ra

Fri May 06 2011By Kaylee McCaffrey

First-of-its-kind technology enables women to benefit from significant reduction of radiation exposure

Women in the US will now have the same opportunity as million of European women already have; to undergo mammography with significantly lower radiation dose. This is the result of FDA’s (Food and Drug Administration) clearance of the Swedish IT and medical technology company Sectra’s digital mammography system, Sectra MicroDose Mammography™. Achieving best-in-class cancer detection, the Sectra MicroDose photon counting technology reduces the radiation dose by half of that used by other digital or film based systems.

“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 in the US have managed to reduce the radiation dose slightly below those of film-based systems,” says Dr. Jesper Söderqvist, 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. Söderqvist.

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 a 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 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. Söderqvist. “Our technology is also the cornerstone in a large European research project for developing and evaluating new revolutionary breast cancer detection methods,” adds Dr. Söderqvist.

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 Linköping 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/index.html

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