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FDA Clears MULTIX Impact C Ceiling-Mounted DR System

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FDA Approves Seno Medical’s Breast Cancer Diagnostic Technology

The Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) has granted Texas-based Seno Medical Instruments Inc.

Philips to Acquire Capsule Technologies Inc.

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USA Today Article Confuses Patients on Benefits of 3D Mammography for Breast Cancer Screening

Hologic points to hundreds of peer-reviewed clinical studies that consistently demonstrate improved outcomes with 3D mammography

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Hologic, Inc. (Nasdaq: HOLX) today objected to the October 24, 2019 USA Today article, “3D mammograms getting the hard sell,” and reaffirmed its position that breast cancer screening with 3D mammography offers women the best chance of early diagnosis.

“This article, which comes as women nationwide are focused on their health during Breast Cancer Awareness Month, is misleading because it is touted as an investigative piece, yet fails to recognize the more than 250 peer-reviewed clinical studies that consistently demonstrate the benefits of 3D mammography over 2D mammography,” said Pete Valenti, Hologic’s Division President, Breast and Skeletal Health Solutions. “Articles like this have the potential to confuse and mislead women into questioning the fact that early detection saves lives. Ultimately, we have to ask, ‘if we don’t screen, what is the alternative?’ At Hologic, we are not willing to wait and let women present with late-stage cancer, when we know breast cancer screening with 3D mammography offers women the best chance of early diagnosis.”

The clinical benefits of 3D mammography are indisputable. Simply put, screening saves lives by identifying cancers earlier. Hologic’s 3D mammography exam has been clinically proven and FDA approved to detect 20 to 65 percent more invasive cancers, reduce unnecessary callbacks by up to 40 percent compared to 2D mammography, and is approved as superior for women with dense breasts compared to 2D alone.[1,2,3,4] Hologic believes the vast majority of doctors understand the benefits of early detection, as do the vast majority of patients who are concerned about themselves, their mothers, sisters and wives.

“3D mammography is unquestionably a superior mammogram,” said Dr. Nila Alsheik, Section Chief, Division of Breast Imaging, Advocate Lutheran General Hospital. “In my practice, I still see 2 to 3 centimeter cancers that are completely occult on 2D mammography, and only visualized on 3D mammography. Even after the tens of thousands of mammograms I’ve read, and the thousands of patients I have counseled, each cancer I detect is like the first one I have ever seen: devastating to that patient, her family and her community. I will do anything to mitigate the confusion that articles like this create.”

“Hologic is proud of the medical community for their unwavering commitment to their patients and for embracing technologies like 3D mammography that continue to find invasive cancers earlier, every day,” Valenti said. “We are also proud of the contributions we have made to the screening, detection and treatment of breast cancer and remain resolute in our commitment to advancing technology to drive accuracy, decreased time to diagnosis, cost effectiveness and patient satisfaction.”

Since the FDA approval of 3D mammography in 2011, breast cancer mortality rates in the U.S. have dropped by 10 percent due to advancements in both screening and treatment.[1,5,6] Yet, there are still far too many women dying from breast cancer – in 2019, 41,760 women are expected to die from breast cancer in the U.S. alone, and more than 500,000 globally.[5,6,7]

SOURCE: Hologic, Inc.

1 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™ mammograms acquired with the Hologic 3D Mammography™ System versus women receiving 2D FFDM mammograms only.

2 Freidewald SM, Rafferty EA, Rose SL, Durand MA, Plecha DM, Greenberg JS, Hayes MK, Copit DS, Carlson KL, Cink TM, Carke LD, Greer LN, Miller DP, Conant EF, Breast Cancer Screening Using Tomosynthesis in Combination with Digital Mammography, JAMA June 25, 2014

3 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.

4 FDA submissions P080003, P080003/S001, P080003/S004, P080003/S005

5 US Mortality Volumes 1930 to 1959, US Mortality Data 1960 to 2016, National Center for Health Statistics, Centers for Disease Control and Prevention

6 NCI Website: https://seer.cancer.gov/statfacts/html/breast.html

7 World Health Organization: Global Health Estimates, 2013

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