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A Better Mammogram
Knowledge is Power
Your Health, Our Mission
Find a Hologic 3D Mammogram

A Better Mammogram
Knowledge is Power
Your Health, Our Mission
Find a Hologic 3D Mammogram

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The Genius^® 3D Mammography™ exam is acquired on the Hologic^® 3D Mammography™ system and consists of a 2D and 3D™ image set, where the 2D image can be either an acquired 2D image or a 2D image generated from the 3D™ image set. The Genius^® exam is only available on the Hologic^® 3D Mammography™ system.
©2022 Hologic Inc. All rights reserved. Hologic, The Science of Sure, 3D, 3D Mammography, 3Dimensions, 3DQuorum, Affirm, ATEC, BioZorb, Brevera, Celero, CeleroMark, Hologic Clarity HD^®, Clarius HD, CorLumina, Dimensions, Eviva, Faxitron, Genius AI^® Detection, Horizon, ImageChecker, I-View, C-View, LOCalizer, MACH, MammoPad, Mammosite, PERL, Quantra, Reconstructive Lumpectomy, SecurView, SecurMark, SecurXchange, Selenia, Sertera, SmartCurve^®, SuperSonic, Trident, TriMark, CeleroMark, TruNode, Tumark, UltraFast, Unifi and associated logos are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners.

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References

*Compared to 2D mammography alone.

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% (95% CI: 20-65%) 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™ mammograms acquired with the Hologic 3D Mammography™ System versus women receiving 2D FFDM mammograms only.
FDA submissions P080003, P080003/S001, P080003/S004, P080003/S005
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.
Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00019 Rev 001 (2017).
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.
Sprague BL, Gangnon RE, Burt V, et al. Prevalence of mammographically dense breasts in the United States. J Natl Cancer Inst. 106(10), 2014.
Data on file DHM-05051_002
Friedewald S, Rafferty E , Rose S, et al. “Breast Cancer Screening using Tomosynthesis in Combination with Digital Mammography.” Journal of the American Medical Association. 2014 July; 311(24):2499-2507. Epub 2014 June 24
Rose S, Tidwell A, Bujnock L, et al. “Implementation of Breast Tomosynthesis in a Routine Screening Practice: An Observational Study.” American Journal of Roentengenology. 2013 Jun; 200(6): 1401-1408. Epub 2013 May 22.
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
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.
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.
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.
Friedewald S, Rafferty E , Rose S, et al. “Breast Cancer Screening using Tomosynthesis in Combination with Digital Mammography.” Journal of the American Medical Association. 2014 July;311(24):2499-2507. Epub 2014 June 24
Skaane P, Bandos A, Gullien R, et al. “Comparison of Digital Mammography Alone and Digital Mammography Plus Tomosynthesis in a Population-based Screening Program.” Radiology. 2013 Apr; 267(1):47-56. Epub 2013 Jan 7.
Ciatto S, Houssami N, Bernardi D, et al. “Integration of 3D Digital Mammography with Tomosynthesis for Population Breast-Cancer Screening (STORM): A Prospective Comparison Study” The Lancet Oncology. 2013 Jun;14(7):583-589. Epub 2013 Apr 25.
Rose S, Tidwell A, Bujnock L, et al. “Implementation of Breast Tomosynthesis in a Routine Screening Practice: An Observational Study.” American Journal of Roentengenology. 2013 Jun; 200(6): 1401-1408. Epub 2013 May 22.
McCarthy A, Kontos D, Synnestvedt M, et al. “Screening outcomes following implementation of digital breast tomosynthesis in a general-population screening program.” J Natl Cancer Inst. 2014 Oct 13;106(11).
Breastcancer. org. US breast cancer statistics. http://www.breastcancer.org/symptoms/understand_bc/statistics. Updated March 10, 2017. Accessed August 17, 2017
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.
Sprague BL, Gangnon RE, Burt V, et al. Prevalence of mammographically dense breasts in the United States. J Natl Cancer Inst. 106(10), 2014.
Kaminska M, Ciszewski T, et al. Breast cancer risk factors. Menopause Review Przeglad Menopauzalny. 2015; 14(3): 196–202. doi: 10.5114/pm.2015.54346.
World Cancer Research Fund International. 2015. Breast cancer statistics. Retrieved 3/13/17 from http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/breast-cancer-statistics.
National Breast Cancer Foundation, Inc. Stages 0 & 1: what does it mean to have stage 1 breast cancer? National Breast Cancer Foundation, Inc. Retrieved 3/31/15 from http://www.nationalbreastcancer.org/breast-cancer-facts.
Breastcancer.org. US breast cancer statistics. Breastcancer.org. http://www.breastcancer.org/symptoms/understand_bc/statistics. Retrieved 5/25/16.
CDC; Breast Cancer Rates Among Black Women and White Women, https://www.cdc.gov/mmwr/volumes/65/wr/mm6540a1.htm?CDC_AA_refVal=https://www.cdc.gov/cancer/dcpc/research/articles/breast_cancer_rates_women.htm
https://www.contemporaryobgyn.net/view/addressing-the-cervical-cancer-screening-disparities-gap
HHS Office of Minority Health; Cancer and Hispanic Americans, https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=61#:~:text=Hispanic%20women%20are%2040%20percent,to%20non%2DHispanic%20white%20women
National Osteoporosis Foundation. NOF.org. What is osteoporosis and what causes it? https://www.nof.org/patients/what-is-osteoporosis/. Accessed 2/10/2021
Outcomes by Race in Breast Cancer Screening With Digital Breast Tomosynthesis Versus Digital Mammography. JACR Volume 18, Issue 7, P906-918, July 01, 2021
Data on file
Monticciolo, D. L., Malak, S. F., Friedewald, S. M., Eby, P. R., Newell, M. S., Moy, L., Destounis, S., Leung, J. W. T., Hendrick, R. E., & Smetherman, D. (2021). Breast cancer SCREENING Recommendations inclusive of all women at Average Risk: Update from the ACR and Society of breast imaging. Journal of the American College of Radiology June 18, 2021. https://www.jacr.org/article/S1546-1440(21)00383-5/fulltext#secsectitle0010.
FDA Approval PMA P080003
FDA Clearance K153486
FDA Clearance K163052
FDA Approval P080003/S006
Division of Cancer Prevention and Control, Centers for Disease Control and Prevention. (2020, September 14). What are the risk factors for breast cancer? What Are the Risk Factors for Breast Cancer? https://www.cdc.gov/cancer/breast/basic_info/risk_factors.htm.
Nixon, C., & Cottrell, P. (2021, April 21). Genetics: Breast cancer risk factors. Breastcancer.org. https://www.breastcancer.org/risk/factors/genetics.
Breast cancer risk factors: Family History. Breastcancer.org/ (2021, April 21). https://www.breastcancer.org/risk/factors/family_history.
National Cancer Institute. (2020, July 14). Dense breasts: Answers to commonly asked questions. Dense Breasts: Answers to Commonly Asked Question. https://www.cancer.gov/types/breast/breast-changes/dense-breasts.
International Agency for Research on Cancer. Latest global cancer data: Cancer burden rises to 19.3 million new cases and 10.0 million cancer deaths in 2020. Press release 292. 15 December 2020
Survival rates for breast cancer. American Cancer Society. (n.d.) https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-survival-rates.html.
Lowry, K. P., Coley, R. Y., Miglioretti, D. L., Kerlikowske, K., Henderson, L. M., Onega, T., Sprague, B. L., Lee, J. M., Herschorn, S., Tosteson, A. N., Rauscher, G., & Lee, C. I. (2020). Screening performance of Digital Breast Tomosynthesis vs DIGITAL Mammography in community practice by patient AGE, SCREENING round, and Breast Density. JAMA Network Open, 3(7). https://doi.org/10.1001/jamanetworkopen.2020.11792
Biopsy. National Breast Cancer Foundation. (2020, October 23). https://www.nationalbreastcancer.org/breast-cancer-biopsy.
ACS Medical Content and News Staff. (2020, September 22). If you're called back after a mammogram. American Cancer Society. https://www.cancer.org/latest-news/if-youre-called-back-after-a-mammogram.html#reviewed_by.
Triple-Negative Breast Cancer. Breastcancer.org: https://www.breastcancer.org/symptoms/types/triple-negative. Accessed October 6, 2021.
Breast calcifications. Mayoclinic.org: https://www.mayoclinic.org/symptoms/breast-calcifications/basics/definition/sym-20050834. Accessed October 6, 2021.
Breast Cancer Hormone Receptor Status. Cancer.org: https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-hormone-receptor-status.html. Accessed October 6, 2021.
Breast Cancer Risk Assessment and Screening in Average-Risk Women. ACOG Practice Bulletin No. 179.
Oeffinger KC, Fontham ETH, Etzioni R, et al. Breast cancer screening for women at average risk: 2015 Guideline Update from the American Cancer Society. JAMA. 2015;314(15):1599-1614.