After being available for several years in Japan, Australia, New Zealand, and throughout Europe, Swedish firm Sectra's digital mammography system has now been approved by the FDA for use in the U.S. (It was also approved for use in Canada in March and in Russia in April.)
"Until now, digital mammography systems in the U.S. have managed to reduce the radiation dose slightly below those of film-based systems," Dr. Jesper Soderqvist, president of Sectra's mammography operations, said in a news release. "Ongoing research shows great promise for further improvements in breast cancer detection with our unique photon-counting technology."
Traditional mammography modalities require a higher dose of radiation to ensure image quality, but MicroDose detects X-ray photons individually via a multi-slit scanning technology that eliminates scattered radiation and reduces the noise level in the resulting image.
At 25 megapixels, the images achieve as much as four times the resolution in other systems. This allows not only for detection of early and subtle changes that occur in malignant cells but also for reduced risk in having annual mammograms.
The company quotes a radiologist in Geneva, Switzerland, as saying: "How can I not choose the mammography system that exposes my patients to the least radiation dose when the image quality is superior?"