Sectra submits PMA (premarket approval application) for "lowest dose" mammography system:
This article was originally published in Clinica
Sectra has submitted the first part of its premarket approval application (PMA) to the US FDA for its Microdose Mammography system, which it claims delivers "by far" the lowest radiation dose in the world. The US is the world's largest mammography market, claimed the Linkoping, Sweden firm, but it was reluctant to speculate on when it expects to gain marketing approval in the country. The Microdose Mammography system uses photon-counting multi-slit technology, which the firm says eliminates electronic noise from the X-ray signal. The device will be priced similarly to standard digital systems. The technology was CE-marked for sale in Europe in 2003.