Philips receives FDA clearance to market MicroDose SI mammography system

   Philips receives FDA clearance to market MicroDose SI mammography system

First full-field digital mammography (FFDM) imaging to set the stage for
future Single-Shot Spectral Imaging applications

PR Newswire

ANDOVER, Mass., Feb. 28, 2013

ANDOVER, Mass., Feb. 28, 2013 /PRNewswire/ -- Royal Philips Electronics (NYSE:
PHG, AEX: PHIA) today announces 510(k) clearance from the Food and Drug
Administration (FDA) for its MicroDose SI system, the first full-field digital
mammography (FFDM) system on the market with the capability to enable future
Single-Shot Spectral Imaging applications*. Philips is working on future
software applications like Spectral Breast Density Measurement*, which will
build upon the MicroDose SI technology.

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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^1. Additionally, high
breast density features a high proportion of connective tissue, which 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—different radiologists may give different
scoring of breast density for the same image.

"Philips believes that spectral imaging technology will be important in
helping clinicians to assess breast density and provide personalized care to
women," says Lakshmi Gudapakkam, Senior Vice President & General Manager of
Diagnostic X-ray and Mammography Solutions, 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."

As in existing Philips MicroDose systems, MicroDose SI uses unique digital
photon-counting technology, which represents a paradigm shift in mammography
by enabling clinicians to conduct exams using low radiation dose without
compromising image quality. Philips has further advanced this unique
technology with Single-Shot Spectral Imaging, which is built upon the fact
that breast density is subject to different tissue types and materials that
absorb X-rays at various energies. The technology powering the MicroDose SI
uses this fundamental behavior of X-rays, allowing clinicians to see more than
just a shadow in mammogram images by separating high and low energy X-ray
within one single exposure.

"The Philips MicroDose SI technology shows great potential," says Etta Pisano,
MD, Dean of the College of Medicine at the Medical University of South
Carolina (MUSC). "I look forward to getting the unit installed at MUSC."

Key advantages of MicroDose SI include:

  oHigh image quality at low X-ray dose (18 to 50 percent lower radiation
    dose than other digital mammography systems^2,3,4,5, with an average dose
    reduction of 40 percent**)
  oShort exam time - less than 5 minutes including image acquisition
  oPatient comfort with anatomically curved and warmed breast support
  oReady for future Single-Shot Spectral Imaging applications*

*Not available in North America

** The actual result of the average dose reduction will vary based on
variations in digital mammography systems

About Royal Philips Electronics

Royal Philips Electronics (NYSE: PHG, AEX: PHIA) is a diversified health and
well-being company, focused on improving people's lives through meaningful
innovation in the areas of Healthcare, Consumer Lifestyle and Lighting.
Headquartered in the Netherlands, Philips posted 2012 sales of EUR 24.8
billion and employs approximately 118,000 employees with sales and services in
more than 100 countries. The company is a leader in cardiac care, acute care
and home healthcare, energy efficient lighting solutions and new lighting
applications, as well as male shaving and grooming, home and portable
entertainment and oral healthcare. News from Philips is located


[1] Boyd NF, Guo H, Martin LJ, et al. Mammographic density and the risk and
detection of breast cancer. N Engl J Med. 356(3):227-36, 2007.
[2] Oduko, J.M. Young, K.C., Burch, A.,: A Survey of Patient Doses from
Digital Mammography Systems in the UK in 2007 to 2009. Digital Mammogr. IWDM
2010, 365–370, (2010).
IRELAND, Radiation Protection Dosimetry , Vol. 145, No. 1, pp. 52–60, (2010).
[4] Leitz W, Almen A. Patientdoser fran rontgenundersokningar i Sverige –
utveckling fran 2005 till 2008. SSM 2010-14, ISSN 2000-0456, available online
(in Swedish) at
[5] White paper, Comparison of Dose Levels in a National Mammography Screening
Program, Philips Healthcare

SOURCE Royal Philips Electronics

Contact: Rachel Bloom-Baglin, Philips Healthcare, Tel: +1-978-659-3748, Email:
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