References: 1*Data on file.
**When Clarity HD high-resolution 3D™ imaging is used in combination with the optional Intelligent 2D™ imaging technology license on SecurView® workstations.
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 2 (95% CI: 0.8 1.6) additional invasive breast cancers per 1,000 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.
The Genius 3D Mammography™ exam (a.k.a. Genius 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.
Please consult your physician for a full list of benefits and risks associated with mammography
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. Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00019 Rev 003 (2017)