Philips Healthcare announced on Thursday that its full-field digital mammography (FFDM) system received 510(k) clearance from the U.S Food and Drug Administration.

According to a statement from the company, the MicroDose SI system is the first FFDM system on the market with the capability to enable future Single-Shot Spectral Imaging applications.

"Philips believes that spectral imaging technology will be important in helping clinicians to assess breast density and provide personalized care to women," said Lakshmi Gudapakkam, senior vice president and general manager of diagnostic X-ray and mammography solutions for Philips Healthcare. "With the MicroDose SI, Philips contributes to breast cancer screening by delivering the same low dose, high image quality and ergonomics it already offers, while supplying clinicians with spectral-ready technology."
Studies have shown that women with dense breast tissue — which often makes it hard for radiologists to see abnormalities on a mammogram — have a higher rate of breast cancer. However, a recent report from the Journal of the National Cancer Institute found breast density was not linked to increased cancer deaths. Nevertheless, the issue is gaining traction in the U.S., driven in part by new legislation. Connecticut was the first state to enact a law three years ago, requiring doctors to inform women of their breast density and possible risks following a mammogram. Similar laws have since been adopted in California, New York, Texas and Virginia. Other states are also considering breast density bills.

Philips has been marketing MicroDose technology ever since it bought the rights to it from its developer, the Swedish firm Sectra, in spring 2011, shortly after it was cleared by the FDA.

Philips said it is working on future software applications like Spectral Breast Density Measurement, which will build upon the MicroDose SI technology.

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