Philips Receives FDA 510(k) Clearance for MicroDose SI Mammography System

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Royal Philips Electronics recently announced that it has received 510(k) clearance from the FDA for its MicroDose SI system, a full-field digital mammography system that has the capability to enable future single-shot spectral imaging applications.

High Breast Density

High breast density is a known risk factor for breast cancer; women with high breast density as seen on a mammogram are four to five times more likely to get breast cancer than women with low breast density. Additionally, high breast density blocks x-rays, making it difficult for clinicians to interpret breast images. As a result, categorization of breast density has become mandatory in many countries and several states in the United States.

Unfortunately, there is not yet a standardized method for assessing breast density, which has limited making use of the density categorization for clinical decisions. The most frequently used method of breast density assessment is subjective manual and visual inspection of the image.

Single-shot Spectral Imaging

As in existing MicroDose systems, MicroDose SI uses unique digital photon-counting technology, which enables clinicians to conduct exams using low-dose radiation without compromising image quality. The technology powering the MicroDose SI, single-shot spectral imaging, separates high- and low-energy x-rays within one single exposure to target different tissue types, enhancing the clarity of mammogram images.

Key advantages of MicroDose SI include:

  • High image quality at low x-ray dose (18% to 50% lower radiation dose than other digital mammography systems, with an average dose reduction of 40%)
  • Short exam time (less than 5 minutes including image acquisition)
  • Patient comfort with anatomically curved and warmed breast support.

“The MicroDose SI … 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,” said­ Lakshmi Gudapakkam, Senior Vice President & General Manager of Diagnostic X-ray and Mammography Solutions, Philips Healthcare. ■