Navigation Links
Philips receives FDA clearance to market MicroDose SI mammography system
Date:2/28/2013

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.

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 density1. 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:

  • High image quality at low X-ray dose (18 to 50 percent lower radiation dose than other digital mammography systems2,3,4,5, 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

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 at www.philips.com/newscenter.


[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, Almen A. Patientdoser fran rontgenundersokningar i Sverige – utveckling fran 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

 


'/>"/>
SOURCE Royal Philips Electronics
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Boston Scientific and Philips Healthcare Announce Collaboration to Enhance Imaging Equipment Offering
2. When Bystanders Become Lifesavers - Launch of Philips SaveLives.net
3. Philips demonstrates innovations in nuclear medicine imaging with a comprehensive portfolio of NM applications for IntelliSpace Portal
4. Philips and Corindus announce distribution agreement to sell Corindus robotic-assisted interventional cardiology system in the United States
5. Philips continues to improve access to treatment for common cause of death in the U.S. with the delivery of its one-millionth AED
6. Philips ermöglicht noch besseren Zugang zu Behandlungen für häufige Todesursache in den USA durch Bereitstellung seines einmillionsten AED
7. Philips and Biocompatibles Team-up to Advance Image Guided Transarterial Embolizations in Interventional Oncology
8. Elekta and Philips Establish Research Consortium to Leverage a Breakthrough in Cancer Care with Integration of a Linear Accelerator and MR Imaging
9. Philips and American Heart Association continue to advance cardiac resuscitation with sixth annual fellowship award
10. University Hospitals and Philips Healthcare to Showcase State-of-the-art Imaging Technology at Cleveland Medical Mart
11. Philips transforms care to address the economic challenges faced by radiology departments and radiologists worldwide
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... MARLBOROUGH, Mass. , April 20, 2017 /PRNewswire/ ... company developing innovative therapeutics that address significant unmet ... new data from the Company,s consumer product development ... technology, at the Society for Investigative Dermatology (SID) ... is to advance and promote the sciences relevant ...
(Date:4/20/2017)... ZappRx, Inc ., a digital health company focused on modernizing ... closed $25 million in Series B funding led by Qiming ... Seattle that is part of a broader ... round included participation from SR One , who led ... (formerly Google Ventures). As part of the financing, Mark ...
(Date:4/20/2017)... 20, 2017 Eyevensys, a private ... non-viral gene expression technology that enables the safe, local, ... address a wide range of ophthalmic diseases, announces it ... products Regulatory Agency (MHRA) to advance its technology into ... ...
Breaking Medicine Technology:
(Date:4/21/2017)... Utah (PRWEB) , ... April 21, 2017 , ... ... wilderness therapy treatment for adolescents and young adults, has kicked off its 4th ... April 23rd. This year’s theme is “Attachment Informed Therapy for Mental Health ...
(Date:4/21/2017)... ... , ... The Patient Advocacy Community of The Beryl Institute presented Eve DeVaro, ... Patient Advocacy Award in recognition of her extraordinary contributions to the field of ... The Beryl Institute’s annual Patient Experience Conference on March 20 in Denver, ...
(Date:4/21/2017)... ... ... Alive for Wellness is a group of clinical professionals and ... Alive team uses advanced behavioral sciences treatment modalities to accomplish their goals. ... struggle is based on 10 modalities of treatment that include: , ...
(Date:4/21/2017)... Ramon, CA (PRWEB) , ... April 21, 2017 , ... ... might not understand the estate planning process, or where to even begin. “Now more ... unresolved if you are to properly protect yourself and your family,” said attorney Lisa ...
(Date:4/21/2017)... GA (PRWEB) , ... April 21, 2017 , ... During ... in Augusta, Georgia. , This festival offers entertainment for everyone — from the ... Heart Garden Festival is a very high quality event held in a grand venue, ...
Breaking Medicine News(10 mins):