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

Barco Presents Multimodality Imaging Display Solutions at SIIM 2017
News | Flat Panel Displays | May 24, 2017
Barco announced that several of its diagnostic display systems will be on display at the 2017 Society for Imaging...
Norwegian Study Confirms Benefits of Pressure-Based Breast Compression for Mammography
News | Mammography | May 22, 2017
Sigmascreening recently announced that a large independent Norwegian study further confirms Sigma’s hypothesis that...
Neiman Institute Releases Breast Screening Bundle Tool
News | Business | May 22, 2017
A new free resource allows radiology practices to estimate professional, technical and global bundled prices for breast...
Seno Medical's Imagio Opto-Acoustic Breast Imaging System Proves Strong Predictor of Malignancy
News | Breast Imaging | May 16, 2017
Seno Medical Instruments Inc. recently announced that is Imagio opto-acoustic (OA/US) breast imaging system results...
Arkansas Surgeon Reports Positive Findings From Use of BioZorb 3-D Marker
News | Radiation Therapy | May 12, 2017
A new research study concluded that use of the BioZorb surgical marker appears to provide better cosmetic outcomes and...
mammography exam

Photo courtesy of Hologic

News | Women's Health | May 11, 2017
Breast cancer is one of the leading causes of death of women worldwide. In Canada, according to the Canadian Cancer...
ABUS

Photo courtesy of GE Healthcare

Feature | Women's Health | May 05, 2017 | By Jeff Zagoudis
Over the last decade, the impact of dense fibroglandular breast tissue on breast cancer screening has become a...
U.S. Clinical Data Supports Echotherapy With Echopulse for Breast Fibroadenomas
News | Focused Ultrasound Therapy | May 04, 2017
Theraclion recently announced the presentation of data from the U.S. feasibility trial of echotherapy with Echopulse, a...
Three-Week Radiation Therapy Treatment Post-Mastectomy Safe and Effective
News | Radiation Therapy | May 02, 2017
A shorter course of radiation therapy given to breast cancer patients following mastectomy is safe and effective and...
Overlay Init