NEWS BRIEF
GE HealthCare’s comprehensive approach to breast cancer careWith breast cancer now surpassing lung cancer as the most commonly diagnosed cancer worldwide, clinicians are seeking tools that can address issues related to access, burnout, variability, and cost in breast imaging to not only enhance the detection and diagnosis of breast cancers, but also help improve overall patient outcomes.
Senographe Pristina™ Mammography Platform:
The Senographe Pristina mammography system was designed to ease anxiety the moment the patient enters the exam room. It features an inviting gantry with elegant lighting and rounded shapes, as well as a soft-curved surface that welcomes patients into a space of comfort and support.
The Senographe Pristina platform today features the Pristina Via TM mammography system, designed to enhance the screening experience for both technologists and patients.
*NEW* Pristina Recon DL
GE HealthCare has received FDA Premarket Authorization for Pristina Recon DL, an advanced 3D mammography image reconstruction technology. Powered by deep learning, Pristina Recon DL sets a new standard in image definition and sharpness.
Pristina Recon DL leverages two deep learning models working in sequence to enable separation of meaningful signal from noise. The first model reconstructs high fidelity 3D volumes with greater purity – minimizing artifacts and perceived noise . The second model is trained to enhance the visualization of clinically relevant information in the DL synthesized 2D view.
Pristina Recon DL is an enhancement to GE HealthCare’s Pristina Via system. It is the first mammography technology to use deep learning in combination with iterative reconstruction to provide outstanding digital breast tomosynthesis (DBT) image quality without compromising on patient dose.
Pristina Via:
As the company continues to evolve the patient-centric Senographe Pristina platform, the new Pristina Via* mammography system is designed to enhance the screening experience for both technologists and patients. This innovation provides mammography technologists with a suite of sophisticated tools that balance the demands of diagnostic accuracy and fast-paced workflows to facilitate more patient-centered breast care.
Pristina Via with Recon DL mammography system offers high clinical confidence and efficient workflows with exceptional patient experience:
• Clear and consistent image quality Superior performance in the detection of microcalcifications and masses, demonstrated in a trial with modeled clinical data2, and the lowest 3D screening dose among major systems on the market3 .
• Efficient workflow: Zero-click acquisition4, zero wait time,5 and personalized protocols to simplify and accelerate exam workflows
• Reliability: 99% uptime, supported by GE HealthCare service contracts and warranty6
• Patient centric: Inclusive design ensures accessibility for all patients, reduces anxiety, and improves comfort with patient assisted compression7
• Advanced applications: 15-minute biopsy exam8 with Serena add-on device and diagnostic accuracy of Contrast Enhanced Mammography with SenoBright™ HD is comparable to breast MRI as demonstrated in multiple studies 9
GE HealthCare developed the Pristina Via to build on its commitment to developing innovations that are driven by people and the challenges they face.
Pristina Dueta™:
An industry-first, our patient- assisted compression remote control device that gives patients a sense of control around their breast compression during a mammogram while under the supervision of a technologist to minimize their discomfort. 10
SenoBright™HD Contrast Enhanced Mammography (CEM):
Performed as a follow-up to an inconclusive mammography and ultrasound, SenoBright™ HD highlights areas of unusual blood flow patterns and helps reduce the masking effect of fibroglandular breast tissue to find lesions that cannot be seen on routine mammography 11,12 ,13 . SenoBright™ HD provides advanced image quality with high specificity to help reduce false-positives and to help prevent unnecessary biopsies and surgeries. The exam can be performed in less than seven minutes – using the same mammography equipment, in the same room, with the same staff. Delivering clear image quality, CEM offers a high level of confidence for clinicians and patients.
Pristina Serena™ 3D Biopsy:
If medical indications recommend pathology, Pristina Serena 3D Biopsy transforms a Senographe Pristina screening room into an interventional suite in just two minutes with the dedicated add-on biopsy kit without requiring a long and mechanical needle installation. Clinicians now have the option of accessing the breast with the newly designed “side approach” to access a larger working space for ease of patient positioning, reducing needle visibility to help ease patient anxiety and allow best access to lesions close to the breast support.
Serena Bright™ Contrast-Guided Biopsy:
The industry’s first contrast-guided biopsy solution designed to biopsy lesions that are otherwise not clearly identifiable. The technology, which received U.S. Food and Drug Administration 510(k) clearance in May 2020, allows patients to have their breast biopsy exams with contrast guidance using the same mammography equipment, in the same room, and with the same staff14 as the screening or diagnostic mammogram.
Pristina Bright**
In an effort to help further advance breast cancer and support healthcare providers in a starting a new contrast program, GE Healthcare’s Pristina Bright** offering provides a comprehensive solution. Pristina Bright combines SenoBright™ HD, Pristina Serena™, and Serena Bright™ with an education program that includes dedicated on-site support, CME accredited self-assessment, as well as access to the users’ club where providers will be able to share with experts around the globe and leverage resources needed to market their facility among referring doctors and patients.
Media contact
Katie Scrivano Senior Communications Manager Women’s Health Katherine.scrivano@gehealthcare.com M: +1 262-215-5281
*Pristina Bright is a commercial offering including SenoBright HD, Pristina Serena and Serena Bright
1 Preference study performed on 140 study cases with 8 MQSA-approved radiologists, trained on clinical image quality by ACR, comparing Pristina Recon DL to ASIR V1.
2 Reader performance evaluation on 19 660 reads with 15 readers using modeled clinical data comparing Pristina Recon DL and ASIR V1.
3 Phantom measurements as of July 2024. Senographe Pristina with default value STD mode. Dose comparison based on NHS Breast Screening Programme equipment.
4 While acquiring within protocols
5 Elapsed time between end of an exposure and system ready in DBT is 2.3s. Measured with ACR phantoms. Pristina Via performance measurement. Data on file GE HealthCare 2024.
6 Analysis of the 42,543 Service request on Pristina platform systems under Contract and Warranty from Oct 2023 to Sept 2024. Since there is no “typical” hospital and many variables exist, i.e. hospital size, working days, working hours, there can be no guarantee that each Pristina system will achieve the same results.
7 IPSOS Patient Satisfaction Study sponsored by GE Healthcare, conducted with 315 patients across 2 sites in Europe, out of which 160 were offered the patient-assisted compression option, February 2017.
8 Data on file. GE HealthCare 2018. Biopsy duration may vary depending on clinical complexity. This duration only represents the time to locate and collected the targeted issue.
9 Based on a comprehensive and systematic review of peer-reviewed scientific literature available at the time of analysis from January 2018 to April 2024 [Link to White Paper]. Most studies indicate that breast MRI has higher sensitivity, while CEM demonstrates higher specificity. Both modalities show comparable area under the curve (AUC) values, indicating similar overall diagnostic accuracy. The comparison between contrast-enhanced mammography (CEM) and breast MRI reflects a summary of published data and does not constitute a generalized clinical claim. Individual clinical decisions should be based on a healthcare professional’s judgment for the specific patient.
10 IPSOS Patient Satisfaction Study sponsored by GE Healthcare, conducted with 315 patients across 2 sites in Europe, out of whi ch 160 were offered the patient-assisted compression option, February 2017
11 Compared to without contrast.
12 J. Sung et al., Radiology 2019; 00; 1-8.
13 V. Sorin et al. American Journal of Roentgenology: W267-W274. 10.2214/AJR.17.1935510(k) K172404.
14 24 Daniaux et al. Arch Gynecol Obstet , 2015