FDA Clears Low-Dose Digital Mammography Unit

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imageThe Food and Drug Administration (FDA) yesterday announced that it has granted Sectra clearance to market its Sectra MicroDose Mammography L30 low-dose digital mammography unit for sale in the U.S.

The first imaging modality of its kind to receive an FDA nod, the system utilizes a technology called photon counting, in which X-ray photons are detected individually. This, Sectra says, 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 megapixels--is two to four times higher resolution than that of other digital systems, the Stockholm, Sweden-based company claims.

Sectra MicroDose is said to be already contributing to significant reductions of radiation doses in major European mammography screening programs. For example, a study of several thousand patients in Ireland found the mean glandular dose from the device was around 1.86 mGy, compared to 2.91 to 3.03 mGy from other systems, according to a presentation by Fidelma Flanagan, clinical director of Ireland’s national breast screening program. Flanagan presented the results of the study at the European College of Radiology’s annual meeting in March.

The system, which received FDA 510 (k) clearance on April 28, has been in use in for more than seven years and is operational in 18 European countries as well as in Australia, New Zealand, and Japan. The FDA approval comes shortly after Russian authorities cleared the device for sale in that nation, and two months after Canada’s health authorities approved it for use by Canadian health care providers. Sectra says it received its first North American order for Sectra MicroDose, from a private radiology practice in Ontario, in March.