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References

Data on file and from public sources, 2021.
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.
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.
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):737-43.7.
Rafferty EA, Durand MA, Conant EF, et al. Breast Cancer Screening Using Tomosynthesis and Digital Mammography in Dense and NondenseBreasts. JAMA. 2016 Apr 26;315(16):1784-
Tech File: TFL-00059
Report: CSR-00116
Physician Labeling: MAN-06153
FDA Submission: P080003/S008
Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00119 Rev 003 (2017).
Data on file: DHM-05051_002.
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
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
Compared to stereotactic biopsy.
Schrading S, Martine D, Dirrichs T, et al. “Digital Breast Tomosynthesis-guided Vacuum-assisted Breast Biopsy: Initial Experiences and Comparison with Prone Stereotactic Vacuum-assisted Biopsy.” Radiology. 2015 274:3, 654-662 E-pub 2014 Nov 12.
Smith A, Sumpkin J, Zuley M, et al. “Comparison of Prone Stereotactic vs. Upright Tomosynthesis Guided Vacuum Assisted Core Breast Biopsies.” (paper presented at the annual meeting for the Radiological Society of North America. Chicago, Il, November 2014).
K122836
FDA PMA submissions P080003/S00, P080003/S006” Labeling MAN-03608
Skaane P, Bandos AI, 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.
Zuley M, Guo B, Catullo V, et al. “Comparison of Two-dimensional Synthesized Mammograms versus Original Digital Mammograms Alone and in Combination with Tomosynthesis Images.” Radiology. 2014 Jun;271(3):664-71. Epub 2014 Jan 21.
Bernardi D, Pellegrini M, Valentini M et al. “The STORM II (Screening with Tomosynthesis or Mammography II) Trial: Interim Comparison of Screen-reading Strategies in Population Breast Screening.” (paper presented at the annual meeting of the Radiological Society of North America, Chicago, Il, December 2014).
Durand M, Raghu M, Geisel J, et al. “Synthesized 2D Mammography + Tomosynthesis: Can We See Clearly?” (paper presented at the annual meeting of the Radiological Society of North America, Chicago, Il, December 2015).
Choi J, Han B, Ko E, et al. “Comparison with Two-Dimensional Synthetic Mammography Reconstructed from Digital Breast Tomosynthesis and Full Field Digital Mammography for the Detection of T1 Breast Cancer.” European Radiology. Epub 2015 Dec.
Woo O, Choi G, Shin H, et al. “Comparative Diagnostic Value of Two-dimensional Synthesized Mammogram and Conventional Full-field Digital Mammogram for Evaluation of Breast Cancer” (poster presented at the annual meeting of the Radiological Society of North America, Chicago, Il, December 2015).
Zuckerman S, Conant E, Weinstein S. “Impact on Recall Rates Following Implementation of Synthesized 2D Mammography in Digital Breast Tomosynthesis Screening.” paper presented at the annual meeting of the Radiological Society of North America, Chicago, IL, December 2015).
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ RadiologicalDevicesPanel/UCM325901.pdf (Slide 20)
Data on file: DHM-05051_002. 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 Onc. 2016 Aug;17(8):1105–1113 Epub 2016 June 23.
Zuckerman S, Conant E, Keller B, et al. “Implementation of Synthesized Two-dimensional Mammography in aPopulation-based Digital Breast Tomosynthesis Screening Program.” Radiology. Epub 2016 July 28.
July 2016 Kadence International Study
Markle, L., et al. “Reduction of Discomfort During Mammography Utilizing a Radiolucent Cushioning Pad.” The Breast Journal 10 (4) (2004) 345-9.
Tabar, L. et al. “Clinical Assessment of a Radiolucent Cushion for Mammography.” Acta Radiologica. 45 (2) (Apr. 2004) 154.
Survey of 280 mammography technologists conducted by Hologic, March 2016.
Watt, A. Christine and Everett-Massetti, E. “Use of a Mammography Comfort Aid and Education to Improve Breast Positioning.” NCBC Poster March-April, 2005, Las Vegas, NV.
Coryell, T. “Increasing Mammography Tissue Acquisition through Positioning Training and Use of a Foam Breast Cushion.” NCBC Poster, March 2006, Las Vegas, NV
FDA 510(k) K163623
Understanding Quantra™ (Version 2.2) User Manual
A novel and fully automated mammographic texture analysis for risk prediction: results from two case-control studies. Wang, C, et al. 2017, Breast Cancer Research, Vol. 19, p. 114.
Mammographic density and structural features can individually and jointly contribute to breast cancer risk assessment in mammography screening: a case–control study. Winkel, RR, et al. 2016, BMC Cancer, Vol. 16, p. 414.
Mammographic texture resemblance generalizes as an independent risk factor for breast cancer. Nielsen M, Vachon CM, Scott CG, Chernoff K, Karemore G, Karssemeijer N, Lillholm M, Karsdal MA. 2014, Breast Cancer Research, Vol. 16(2), p. R37
AWS with minimum 3Dimensions 2.1 or Selenia Dimensions 1.10 software
Pinkney and Shah, 2013. A prospective comparative study to evaluate the displacement of four commercially available breast biopsy markers. British Journal of Radiology. 2016;89(1065). (GelMark, HydroMARK, SecurMark, SENOMARK, and UltraClip by Bard (BioDur® 108 core)). Yen et al., 2018. Post–Vacuum-Assisted Stereotactic Core Biopsy Clip Displacement: A Comparison Between Commercially Available Clips and Surgical Clip. Canadian Association of Radiologists Journal. 2018;69(1):10-15. Additional details available on file.
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.
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.
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.
Rafferty EA, Durand MA, Conant EF, et al. Breast Cancer Screening Using Tomosynthesis and Digital Mammography in Dense and NondenseBreasts. JAMA. 2016 Apr 26;315(16):1784-6.
Data collected from 100 cases performed at various sites using the Sertera® biopsy device.
Ultrafast Ultrasound Imaging, by Jeremy Bercoff (Published: August 23rd 2011 DOI: 10.5772/19729)
FDA Clearance: K201019
DHM-10095-002, MAN-036822-Understanding R2 ImageChecker CAD 10.0. Image Checker PMA Approval P970058
Compared to the MultiCare®Platinum system
Tech File: TFL-00059
Report: CSR-00116
Physician Labeling: MAN-06153
FDA approval number.P080003/S008
White Paper, WP-00152
FDA Approval reference P080003/S006
Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00119 Rev 003 (2017)
Smith, A. SmartCurve™ Breast Stabilization System Patient Experience in Routine Clinical Use. Hologic WP-00141 Rev 001 (2/19).
Wilson A. Trident 2.0 QUAL Qualitative Findings. Explore and identify the ideal breast biopsy verification system from the OR. Kadence International. July 2016.
Compared to original Trident system, which is not available in Europe
Data on file and from public sources, 2017.
Tech File: TFL-00059
Report: CSR-00116
Physician Labeling: MAN-06153
FDA Approval : P080003/S008
Compared to 2D.
N = 337 patients prospectively followed through a registry. Kaufman CS, et al. Registry Study of 337 Bio-Absorbable 3-D Implants Marking Lumpectomy Cavity Benefit Cosmesis While Targeting Radiation. Poster presented at the Society of Surgical Oncology Annual Cancer Conference March 15-17, 2017. DISCLAIMER: The cosmesis indications referred to in this publication have not been reviewed by FDA.
Upon purchase cloud storage may be removed.
Compared to the MultiCare® Platinum system.
Superior 2D/3D™ biopsy imaging based on the same detector technology as in the Selenia® Dimensions® mammography system.
3D™ Breast Biopsy option.
Compared to existing dedicated prone biopsy systems.
Compared to a standard 2D stereotactic procedure.
Through the 510(k) process
King TA, Bolton JS, Kuske RR, et al. Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for Tis1,2 breast cancer. Am J Surg. 2000; 180:299-304.
Shah C, Badiyan S, Ben Wilkinson J, Vicini F, Beitsch P, Keisch M, Arthur D, Lyden M. Treatment Efficacy With Accelerated Partial Breast Irradiation (APBI): Final Analysis of the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial. Ann Surg Oncol. 2013 Aug 22. [Epub ahead of print] PubMed PMID: 23975302
Benitez PR, Keisch ME, Vicini F, Stolier A, Scroggins T, Walker A, et al. Five-year results: the initial clinical trial of MammoSite balloon brachytherapy for partial breast irradiation in early-stage breast cancer. Am J Surg 2007;194:456-62
IMV, Ltd rankings
Kaufman CS, et al. Registry Study of 337 Bio-Absorbable 3-D Implants Marking Lumpectomy Cavity Benefit Cosmesis While Targeting Radiation. Poster presented at the Society of Surgical Oncology Annual Cancer Conference March 15-17, 2017.
Harms S, et al. Mammographic imaging after partial breast reconstruction: Impact of a bioabsorbable breast implant. J Clin Oncol 33, 2015 (suppl 28S; abstr 111)
Eastell, R., et al. Effect of anastrozole on bone mineral density; 5-year results from the anastrozole, tamoxifen, alone or in combination trial 18233230. J Clin Oncol. 2008. Official journal of the American Society of Clinical Oncology, 26(7), 1051–1057. https:// doi.org/10.1200/JCO.2007.11.0726
Freedman et al. Weight and body composition changes during and after adjuvant chemotheraphy in women with breast cancer. J Clin Endocrincol Metab. 2004
Cespedes Feliciano, E.M., Chen, W.Y., et al. (2019). Adipose Tissue Distribution and Cardiovascular Disease Risk Among Breast Cancer Survivors. Journal of clinical oncology: official journal of the American Society of Clinical Oncology, 37(28), 2528–2536. https://doi.org/10.1200/JCO.19.00286. https:// www.ncbi.nlm.nih.gov/pmc/articles/PMC7001794/
Meyer, M. R., Clegg, D. J., et al. (2011). Obesity, insulin resistance and diabetes: sex differences and role of oestrogen receptors. Acta physiologica (Oxford, England), 203(1), 259–269. https://doi.org/10.1111/ j.1748-1716.2010.02237.x. https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC3110567/#S4title
Jankowski, L et al (2006) Quantifying Image Quality of DXA Scanners Performing Vertebral Fracture Assessment Using Radiographic Phantoms, Cooperatively with: Illinois Bone and Joint Institute, Morton Grove, IL and Division of Endocrinology University of Chicago Hospitals, Chicago, IL
Shah C, Badiyan S, Ben Wilkinson J, Vicini F, Beitsch P, Keisch M, Arthur D, Lyden M. Treatment Efficacy with Accelerated Partial Breast Irradiation (APBI): Final Analysis of the American Society of Breast Surgeons MammoSite® Breast Brachytherapy Registry Trial. Ann Surg Oncol. 2013 Aug 22. [Epub ahead of print] PubMed PMID: 23975302.
LuSM, ScanderbegDJ, BarnaP, YasharW, YasharC .Evaluation of Two Intracavitary high-dose-rate Brachytherapy Devices for Irradiating Additional and Irregularly Shaped Volumes of Breast Tissue. Article in Press Medical Dosimetry (2011), p3.
King TA, Bolton JS, Kuske RR, et al. Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for Tis1,2 breast cancer. Am J Surg. 2000; 180:299-304.
Based on Tumark® Data Collection Study, 3 clinicians at 3 hospitals for 71 marker placements, 2017.
Based on Tumark® Data Collection Study, 3 clinicians at 3 hospitals for 45 marker placements, 2017.
Based on Tumark® Data Collection Study, 3 clinicians at 3 hospitals for 90 marker placements, 2017.
Not available in all markets
Phillips J, et al., Contrast-enhanced spectral mammography (CESM) versus MRI in the high-risk screening setting: patient preferences and attitudes. Clin Imaging. Mar - Apr 2017.
Data on file at Hologic, Inc.
Hologic data on file, Internal testing performed at Hologic and maintained in PLM system.
Compared to Mammatome and Vacor. M. Scarth, W. Teh; Harrow/UK. MR-guided vacuum-assisted core-needle breast biopsy: Comparison of three vacuum-assisted biopsy devices. ECR Congress 2009. Scientific Paper, e-Poster: B-295.
Brevera Pulse Survey. Quantitative report. Inspired Insights. April 2019.
Results from “A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera® Breast Biopsy System” (NCT03300206) (US)
MISC-04810
Compared to the Eviva® device. Data on file.
Data on file at Hologic, Inc.
Englander, B. White Paper. 2013, Hologic WP-00006.
Hologic data on file,Hologic Sales data, Quintiles IMS procedure data, Internal share estimates as of 10/2018
Schrading S, Simon B, Braun M, Wardelmann E, Schild H, Kuhl C. MRI-Guided Breast Biopsy: Influence of Choice of Vacuum Biopsy System on the Mode of Biopsy of MRI-Only Suspicious Breast Lesions. AJR 2010;194:1650-1657.
MISC-04810, Compared with stereotactic (2D) biopsy
MISC-04810; compared to ATEC® breast biopsy device.

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