by
Brendon Nafziger, DOTmed News Associate Editor | May 04, 2011
The Food and Drug Administration said Wednesday it cleared Sectra's low-dose digital mammography unit for sale in the United States.
The Swedish medical device company said the digital system, MicroDose Mammography L30, uses a technology called photon counting in which X-ray photons are detected individually. This method cuts the radiation dose to patients in half, compared to some digital or film equipment.
"[A] woman undergoing regular mammography examinations is exposed to radiation every time she is screened, and so it is important to minimize radiation dose," Dr. Stamatia Destounis, managing partner of Elizabeth Wende Breast Care LLC. in Rochester, N.Y., said in a statement.
A recent examination of thousands of patients in Ireland found the mean glandular dose from the Sectra device was around 1.86 mGy, compared to 2.91-3.03 mGy from other models tested, according to a presentation by Fidelma Flanagan, clinical director of the national breast screening program in Ireland.
The study was presented at the European College of Radiology's annual convention in March, and archived on Sectra's website.
The FDA said it approved the Stockholm-based company's 510(k) application on April 28. The approval comes only some weeks after Russian health authorities also cleared the device for sale.
Sectra received an order for the first North American shipment, to a private radiology practice in Ontario, in March. Canada's health authorities
approved the system in February.
The MicroDose system has been available for seven years, Sectra said, and is currently sold in 18 European countries, Australia, New Zealand and Japan.
Carole Lamarque
new mammo machine
May 05, 2011 09:47
very pleased by what I read, even more pleased
to see that it was promptly approved/cleared by
the fda. cost was not mentioned. what is it?
VS the benefit? dose seems cut tremendously, but
mammos tend to be done in the us on older women
where dose is not really an issue, or a lesser one
at least. in europe and elsewhere, younger women
are more often screened, which is where the cut in
dose is a huge plus!
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