SenoBright™ HD

Contrast-Enhanced Mammography advanced application

Reduces the masking effect of breast tissue to reveal what matters1.
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At a Glance

High sensitivity

Results in accurate breast cancer diagnosis1.

Quick and efficient

Takes down 7 minutes to perform a SenoBright HD exam2.
30 CEM exams a day3.

High specificity

For low false-positives and help prevent unnecessary exams1.

Care for more patients

43% of patients wouldn’t come back for follow-up4.

See differently, see clearly, see in contrast

Provide answers to your patients right away and help them avoid the agonizing wait that comes with an inconclusive exam. Don’t seek, see. Accelerate your ability to make a confident diagnosis.
ASTONISHING CLARITY

The image you need is never out of reach

• Helps reduce the masking effect of fibroglandular breast tissue and increases the tumour signal1.
• Contrast agent highlights areas of unusual blood flow.
• CEM is an alternative imaging method to MRI, especially when MRI availability is limited, and for patients for whom MRI is contraindicated5.
EXCEPTIONAL PERFORMANCE

Improve clinical accuracy

• Find lesions that cannot be seen on routine mammography6,7,8.
• Provide high specificity for low false-positives1.
• With Nira, overall Image quality was better assessed in more than 98% of the images presented by all the readers9.
GROW YOUR PRACTICE

Care for more patients

• Expand to a large population of women who can access this technology for Equitable care.
• Reduce agonizing wait time for women to get to a confident diagnosis.
• Target the 43% of patients who would not come back for follow-up4.
BOOST PRODUCTIVITY

Consistently acquire 30 CEM exams a day3

• Filter out false positives to make room for those in true need1.
• Meets reimbursement criterion for this exam without pre-authorization.
• Can perform the imaging exam in less than 7 minutes2, on a machine and with staff women are familiar with.
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GET IN TOUCH

Have a question? We would love to hear from you.

References
1. 510(k) K172404.

2. Data on file. GE HealthCare 2017.

3. Over 8 hours. Data on file, GE HealthCare 2019.

4. Andrew Mosier DO, Esha Gupta MD, Dana Ataya MD, Kavita Bhatt MD, Alice Rim MD.
March 2017. https://doi.org/10.1111/tbj.12784.

5. Phillips et al. Workflow Considerations for Incorporation of Contrast-Enhanced Spectral
Mammography Into a Breast Imaging Practice, ACR, 2018 https://www.jacr.org/article/S1546-1440(18)30205-9/fulltext

6. Compared to without contrast.

7. J. Sung et al., Radiology 2019; 00:1-8.

8. V. Sorin et al. American Journal of Roentgenology: W267-W274. 10.2214/
AJR.17.1935510(k) K172404.

9. 510(k) K211215. Reader study performed by 3 MQSA qualified radiologists on 50 clinical
images, comparing SenoBright HD with NIRA to current version.

* Superior diagnostic accuracy demonstrated in a reader study comparing the ROC AUC of GE screening protocol (V-Preview + 3D CC/MLO with 3D in STD mode) to that of 2D FFDM alone. V-Preview is the 2D synthesized image generated by GE Seno Iris mammography software from GE DBT images. FDA PMA P130020 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130020.

** As compared to Pristina Serena 2D biopsy. Data on file GE HealthCare 2018.

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