References


  1. FDA submissions P080003, P080003/S001, P080003/S004, P080003/S005
  2. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014 Jun 25;311(24):2499-507.
  3. Zuckerman SP, Conant EF, Keller BM, et al. Implementation of Synthesized Two-dimensional Mammography in a Population-based Digital Breast Tomosynthesis Screening Program. Radiology. 2016 Dec;281(3):730-736.
  4. Skaane P, Bandos A, Eben EB, et al. Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Radiology. 2014 Jun;271(3):655-63.
  5. Bernardi D, Macaskill P, Pellegrini M, et. al. Breast cancer screening with tomosynthesis (3D mammography) with acquired or synthetic 2D mammography compared with 2D mammography alone (STORM-2): a population-based prospective study. Lancet Oncol. 2016 Aug;17(8):1105-13.
  6. McDonald ES, Oustimov A, Weinstein SP, et al. Effectiveness of Digital Breast Tomosynthesis Compared With Digital Mammography: Outcomes Analysis From 3 Years of Breast Cancer Screening. JAMA Oncol. 2016 Jun 1;2(6):737-43.
  7. Rafferty EA, Durand MA, Conant EF, et al. Breast Cancer Screening Using Tomosynthesis and Digital Mammography in Dense and Nondense Breasts. JAMA. 2016 Apr 26;315(16):1784-6.
  8. Results from Friedewald, SM, et al. "Breast cancer screening using tomosynthesis in combination with digital mammography." JAMA 311.24 (2014): 2499-2507; a multi-site (13), non-randomized, historical control study of 454,000 screening mammograms investigating the initial impact the introduction of the Hologic Selenia Dimensions on screening outcomes. Individual results may vary. The study found an average 41% increase and that 1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1000 screening exams were found in women receiving combined 2D FFDM and 3D(TM) mammograms acquired with the Hologic 3D Mammography(TM) System versus women receiving 2D FFDM mammograms only.
  9. Data on file. Hologic
  10. Gur D, Wallace LP, Klym AH, et al. Trends in recall, biopsy, and positive biopsy rates for screening mammography in an academic practice. Radiology. 2005;235(2):396-401.
  11. Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00019 Rev 001 (2017).
  12. Pisano E, Gatsonis C, Hendrick E, et al. Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med. 2005;353:1773-1783.
  13. Schell MJ, Yankaskas B, Ballard-Barbash R, et al. Evidence-based target recall rates for screening mammography. Radiology. 2007;243(3):681-689.
  14. Rosenberg RD, Yankaskas BC, Abraham LA, et al. Performance benchmarks for screening mammography. Radiology. 2006;241(1):55-66.
  15. Patel H. Women want breast cancer screening with better detection and fewer follow-up tests [press release]. Washington, DC; Society for Women’s Health Research; October 31, 2014. http://swhr.org/resource/women-want-breast-cancer-screening-with-better-detection-and-fewer-follow-up-tests/. Accessed April 8, 2015.
  16. Philpotts LE, Kalra VB, Crenshaw J, Butler RS. How tomosynthesis optimizes patient work up, throughput, and resource utilization. Abstract presented at: Radiological Society of North America Scientific Assembly and Annual Meeting; December 1-6, 2013; Chicago, IL.
  17. National Breast Cancer Foundation, Inc. Stages 0 & 1: what does is mean to have stage 1 breast cancer? http://www.nationalbreastcancer.org/breast-cancer-stage-0-and-stage-1. Accessed August 28, 2017
  18. Ho JM, Jafferjee N, Covarrubias GM, Ghesani M, Handler B. Dense breasts: a review of reporting legislation and available supplemental screening options. AJR Am J Roentgenol. 203(2):449-56, 2014.
  19. Sprague BL, Gangnon RE, Burt V, et al. Prevalence of mammographically dense breasts in the United States. J Natl Cancer Inst. 106(10), 2014.
  20. What do women know about breast density? Results from a population survey of Virginia women. Health Services Research and Policy.
  21. Lordache, R. (2015) Quality Control for SenoClaire (GE Breast Tomosynthesis) retrieved on June 9, 2017 from http://amos3.aapm.org/abstracts/pdf/97-26965-352470-110105-667065451.pdf
  22. Mammomat Inspiration with PRIME Technology brochure retrieved on June 9, 2017 from https://static.healthcare.siemens.com/siemens_hwem-hwem_ssxa_websites-context-root/wcm/idc/groups/public/@global/@imaging/@mammo/documents/download/mda1/nzez/~edisp/mammography_mammomat_inspiration_prime_mammography_screening_machine_product_brochure-feb-16-02678877.pdf
  23. www.itnonline.com Breast Tomosynthesis Systems Comparison Chart retrieved on October 9, 2017 from https://www.itnonline.com/compare/76036/50483?products=1-5
  24. For breasts of 4.5cm or smaller
  25. Ten Thousand Quantitative Findings Research Study; Kadence International (April 2017)
  26. Data from bettermammogrampoll.com 3/29/16 – 9/27/16.
Visit
Tweet Email