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- \nGE HealthCare has received FDA Premarket Authorization for Pristina Recon DL, an innovative 3D mammography reconstruction application.\n<\/li>\n
- \nPowered by artificial intelligence (AI), Pristina Recon DL delivers sharper images with fewer artifacts, enhanced details, and greater consistency1<\/sup> \u2013 helping clinicians make more confident diagnoses.\u00a0\n<\/li>\n<\/ul>\n
CHICAGO–(BUSINESS WIRE<\/a>)–
\nGE HealthCare (Nasdaq: GEHC) announced today that it has received FDA Premarket Authorization for Pristina Recon DL<\/b>, an advanced 3D mammography image reconstruction technology. Powered by deep learning, Pristina Recon DL sets a new standard in image definition and sharpness.\n<\/p>\n\nBreast cancer remains one of the most common cancers among women, with one in eight expected to face a diagnosis in their lifetime2<\/sup> and an estimated 1.1 million breast cancer\u2013related 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.\n<\/p>\n
\nPristina 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 \u2013 minimizing artifacts and perceived noise1<\/sup>. The second model is trained to enhance the visualization of clinically relevant information in the DL synthesized 2D view.\n<\/p>\n
Deep learning models reconstruct images with scientific precision<\/b><\/p>\n
\nPristina Recon DL is an enhancement to GE HealthCare\u2019s Pristina ViaTM<\/sup> 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<\/sup> 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.\n<\/p>\n
\n\u201cPristina Recon DL was born out of a deep commitment to our customers \u2013 listening closely to their feedback and working hand-in-hand with radiologists to enhance image quality and clarity,\u201d said Jyoti Gupta, PhD, President and CEO, Women\u2019s Health and X-ray at GE HealthCare. \u201cBy applying advanced deep learning technologies, we\u2019re shaping the future of breast imaging \u2013 one defined by uncompromised image quality, faster workflows, and greater confidence in early cancer detection.\u201d\n<\/p>\n
\nA 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<\/sup> It also offers superior performance in the detection of microcalcification clusters and masses, demonstrated in a trial with modeled clinical data.5<\/sup><\/p>\n
\n\u201cOur 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,\u201d said Dr. Howard Berger, President and Chief Executive Officer of RadNet. \u201cThis pioneering AI technology will help elevate breast care by delivering the clarity and consistency radiologists need to enable more confident diagnoses.\u201d\n<\/p>\n
\nPristina Via with Recon DL mammography system offers high clinical confidence and efficient workflows with exceptional patient experience:\n<\/p>\n
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- Clear and consistent image quality:<\/b> Superior performance in the detection of microcalcifications and masses, demonstrated in a trial with modeled clinical data,6<\/sup> and the lowest 3D screening dose among major systems on the market7<\/sup>.\n<\/li>\n
- Efficient workflow:<\/b> Zero-click acquisition,8<\/sup> zero wait time,9<\/sup> and personalized protocols to simplify and accelerate exam workflows\n<\/li>\n
- Reliability<\/b>: 99% uptime, supported by GE HealthCare service contracts and warranty10<\/sup><\/li>\n
- Patient centric:<\/b> Inclusive design ensures accessibility for all patients, reduces anxiety, and improves comfort with patient assisted compression11<\/sup><\/li>\n
- Advanced applications<\/b>: 15-minute biopsy exam12<\/sup> with Serena add-on device and diagnostic accuracy of Contrast Enhanced Mammography with SenoBright\u2122 HD is comparable to breast MRI as demonstrated in multiple studies13<\/sup><\/li>\n<\/ul>\n
\n\u201cWith Pristina Via with Recon DL, we\u2019re setting a new benchmark in breast imaging \u2014 delivering sharper, clearer, and more consistent images14<\/sup> that empower radiologists with more confidence,\u201d said Pooja Pathak, Vice President and General Manager, Mammography at GE HealthCare. \u201cAs an upgradable feature on the Pristina Via platform, we are excited to now offer customers uncompromised image quality combined with fast, accurate workflows.\u201d\n<\/p>\n
\nGE 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 \u2013 making it difficult for cancer to hide.\n<\/p>\n
\n\u201cWe 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,\u201d said Dr. Gary Dee, President, Midstate Radiology Associates, LLC. \u201cNow, with the introduction of Pristina Recon DL, we\u2019re excited to see a new level of image quality that reinforces our confidence in delivering breast cancer care.\u201d\n<\/p>\n
\nFor more information on Pristina Recon DL and the latest mammography advancements from GE HealthCare, visit the GE HealthCare Events Center<\/a> or the company\u2019s booth 7334 at RSNA through Dec. 4.\n<\/p>\n
About GE HealthCare Technologies Inc.<\/b><\/p>\n
\nGE 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\u2019s 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.\n<\/p>\n
\nGE HealthCare is proud to be among 2025 Fortune World\u2019s Most Admired Companies\u2122<\/a>.\n<\/p>\n
\nFollow us on LinkedIn<\/a>, X<\/a>, Facebook<\/a>, Instagram<\/a>, and Insights<\/a> for the latest news, or visit our website https:\/\/www.gehealthcare.com<\/a> for more information.\n<\/p>\n
- Efficient workflow:<\/b> Zero-click acquisition,8<\/sup> zero wait time,9<\/sup> and personalized protocols to simplify and accelerate exam workflows\n<\/li>\n
- Clear and consistent image quality:<\/b> Superior performance in the detection of microcalcifications and masses, demonstrated in a trial with modeled clinical data,6<\/sup> and the lowest 3D screening dose among major systems on the market7<\/sup>.\n<\/li>\n
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