Feature | February 28, 2013

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

MicroDose SI

Royal Philips Electronics announced it received 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.

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,” said Lakshmi Gudapakkam, senior vice president and 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,” said Etta Pisano, M.D., 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:

•       High 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**)

•    Short exam time - less than 5 minutes including image acquisition

•    Patient comfort with anatomically curved and warmed breast support

•    Ready 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

For more information: www.healthcare.philips.com

[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).

3 Baldelli P., et. al., COMPREHENSIVE DOSE SURVEY OF BREAST SCREENING IN IRELAND, Radiation Protection Dosimetry , Vol. 145, No. 1, pp. 52–60, (2010).

4 Leitz W, Almén A. Patientdoser från röntgenundersökningar i Sverige – utveckling från 2005 till 2008. SSM 2010-14, ISSN 2000-0456, available online (in Swedish) at www.stralsakerhetsmyndigheten.se.

5 White paper, Comparison of Dose Levels in a National Mammography Screening Program, Philips Healthcare

[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).

[3] Baldelli P., et. al., COMPREHENSIVE DOSE SURVEY OF BREAST SCREENING IN IRELAND, Radiation Protection Dosimetry , Vol. 145, No. 1, pp. 52–60, (2010).

[4] Leitz W, Almén A. Patientdoser från röntgenundersökningar i Sverige – utveckling från 2005 till 2008. SSM 2010-14, ISSN 2000-0456, available online (in Swedish) at www.stralsakerhetsmyndigheten.se.

[5] White paper, Comparison of Dose Levels in a National Mammography Screening Program, Philips Healthcare

 

 

 

 

 

 

 

 

Related Content

Explaining the Mammography Quality Standards Act
Feature | Mammography | October 16, 2018
The Mammography Quality Standards Act (MQSA) was enacted to improve the quality of mammography and ensure that all...
iCAD Announces Positive Clinical Results for Artificial Intelligence Tomosynthesis Technology
News | Mammography | October 11, 2018
iCAD Inc. announced positive clinical results of its new digital breast tomosynthesis (DBT) cancer detection software,...
"Where's My Mammogram?" Campaign Helps Women Own Breast Health Records
News | Breast Imaging | October 10, 2018
October 10, 2018 — Mammosphere launched “Where’s My Mammogram?,” a public service campaign to help women obtain copie
DenseBreast-info.org Launches European Expansion
News | Breast Density | October 10, 2018
DenseBreast-info.org (DB-I) announced the launch of its international expansion for European medical providers. The...
X-ray Mammography Adoption to Skyrocket for Breast Cancer Detection
News | Mammography | October 08, 2018
Highly populated countries have traditionally been slow adopters of non-conventional business models, but a new Frost...
Cullman Regional Medical Center

Cullman Regional Medical Center (Alabama) is a 145-bed medical center serving more than 175,000 residents in a six-county area and recognized as one of the region’s finest medical facilities.

Sponsored Content | Case Study | PACS | October 05, 2018
When Cullman Regional Medical Center in Alabama decided to switch from 2-D
Feature | Mammography | October 05, 2018 | By Jeff Zagoudis
“Patient-centered care” is a popular term among those in the healthcare industry in the 21st century. It means the...
Feature | Breast Imaging | October 04, 2018 | By Tracy Accardi
It has been nearly eight years since the world’s first digital breast tomosynthesis (DBT) mammography technology was...
Leica Biosystems Launches MammoPort Specimen Containment and Transport System
Technology | Breast Biopsy Systems | October 03, 2018
Leica Biosystems announced the U.S. launch of MammoPort, the first integrated specimen containment and transport system...
Xoft Electronic Brachytherapy System Effective Long-Term for Early-Stage Breast Cancer
News | Brachytherapy Systems, Women's Healthcare | October 02, 2018
Breast cancer recurrence rates for patients treated with the Xoft Axxent Electronic Brachytherapy (eBx) System that...