- GE HealthCare has received FDA Premarket Authorization for Pristina Recon DL, an innovative 3D mammography reconstruction application.
- Powered by artificial intelligence (AI), Pristina Recon DL delivers sharper images with fewer artifacts, enhanced details, and greater consistency1 – helping clinicians make more confident diagnoses.
GE HealthCare (Nasdaq: GEHC) announced today that it 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.
Breast cancer remains one of the most common cancers among women, with one in eight expected to face a diagnosis in their lifetime2 and an estimated 1.1 million breast cancer–related deaths projected annually by 2050. As the burden of disease continues to rise, the advancement of AI-powered technologies holds remarkable promise in supporting early detection, accurate diagnosis and helping elevate the quality of care.
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 noise1. The second model is trained to enhance the visualization of clinically relevant information in the DL synthesized 2D view.
Deep learning models reconstruct images with scientific precision
Pristina Recon DL is an enhancement to GE HealthCare’s Pristina ViaTM 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 with Recon DL3 utilizes NVIDIA RTX accelerated computing technology to execute its advanced image reconstruction, delivering fast and accurate images in the exam room and for clinical diagnosis.
“Pristina Recon DL was born out of a deep commitment to our customers – listening closely to their feedback and working hand-in-hand with radiologists to enhance image quality and clarity,” said Jyoti Gupta, PhD, President and CEO, Women’s Health and X-ray at GE HealthCare. “By applying advanced deep learning technologies, we’re shaping the future of breast imaging – one defined by uncompromised image quality, faster workflows, and greater confidence in early cancer detection.”
A recent study showed that Pristina Recon DL overall image quality was preferred by breast radiologists in 99.1% of the image reviews compared to previous DBT reconstruction.4 It also offers superior performance in the detection of microcalcification clusters and masses, demonstrated in a trial with modeled clinical data.5
“Our collaboration with GE HealthCare has been instrumental in advancing breast imaging capabilities, and the new 3D image quality represents a meaningful upgrade that will benefit radiologists and patients alike,” said Dr. Howard Berger, President and Chief Executive Officer of RadNet. “This pioneering AI technology will help elevate breast care by delivering the clarity and consistency radiologists need to enable more confident diagnoses.”
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 data,6 and the lowest 3D screening dose among major systems on the market7.
- Efficient workflow: Zero-click acquisition,8 zero wait time,9 and personalized protocols to simplify and accelerate exam workflows
- Reliability: 99% uptime, supported by GE HealthCare service contracts and warranty10
- Patient centric: Inclusive design ensures accessibility for all patients, reduces anxiety, and improves comfort with patient assisted compression11
- Advanced applications: 15-minute biopsy exam12 with Serena add-on device and diagnostic accuracy of Contrast Enhanced Mammography with SenoBright™ HD is comparable to breast MRI as demonstrated in multiple studies13
“With Pristina Via with Recon DL, we’re setting a new benchmark in breast imaging — delivering sharper, clearer, and more consistent images14 that empower radiologists with more confidence,” said Pooja Pathak, Vice President and General Manager, Mammography at GE HealthCare. “As an upgradable feature on the Pristina Via platform, we are excited to now offer customers uncompromised image quality combined with fast, accurate workflows.”
GE HealthCare worked with academic institutions and high-volume outpatient imaging centers to develop and validate the algorithms at each stage of the development process. Pristina Recon DL goes beyond reconstruction to prioritize what matters most for radiologists – making it difficult for cancer to hide.
“We value GE HealthCare listening and innovating with us in mammography. Upgrading to Pristina Via has refined our exam workflow, making it more efficient and patient-focused,” said Dr. Gary Dee, President, Midstate Radiology Associates, LLC. “Now, with the introduction of Pristina Recon DL, we’re excited to see a new level of image quality that reinforces our confidence in delivering breast cancer care.”
For more information on Pristina Recon DL and the latest mammography advancements from GE HealthCare, visit the GE HealthCare Events Center or the company’s booth 7334 at RSNA through Dec. 4.
About GE HealthCare Technologies Inc.
GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient’s journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits.
GE HealthCare is proud to be among 2025 Fortune World’s Most Admired Companies™.
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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. |
Pristina Recon DL is the reconstruction algorithm of Senographe Pristina 3D. |
2 National Cancer Institute. “Breast Cancer Risk Factors.” Cancer.gov. Accessed November 2025. https://www.cancer.gov/types/breast/risk-fact-sheet |
3 Pristina Recon DL is an optional AI-based reconstruction solution of Senographe Pristina 3D. |
4 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. |
5 Reader performance evaluation on 19 660 reads with 15 readers using modeled clinical data comparing Pristina Recon DL and ASIR V1. |
6 Reader performance evaluation on 19 660 reads with 15 readers using modeled clinical data comparing Pristina Recon DL and ASIR V1. |
7 Phantom measurements as of July 2024. Senographe Pristina with default value STD mode. Dose comparison based on NHS Breast Screening Programme equipment. |
8 While acquiring within protocols |
9 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. |
10 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. |
11 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. |
12 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. |
13 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. |
14 Performance test report. Data on file GE HealthCare 2018. 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. |
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