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.