FDA clears Sectra's digital mammography system

Sectra (STO:SECTB): 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 (http://www.sectra.com/medical/mammography/solutions/microdose/index.html). Achieving best-in-class cancer detection (http://newsroom.sectra.com/2011/03/webcasts-from-the-ecr-mammography-symposium/#more-642), the Sectra MicroDose photon counting (http://www.sectra.com/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.

"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.

Source: Sectra