GE HealthCare has received FDA Premarket Authorization for Pristina Recon DL, an innovative 3D mammography reconstruction application.

GE HealthCare 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.

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Deep learning models reconstruct images with scientific precision

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 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. 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.”

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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, and the lowest 3D screening dose among major systems on the market.
  • Efficient workflow: Zero-click acquisition, zero wait time, and personalized protocols to simplify and accelerate exam workflows
  • Reliability: 99% uptime, supported by GE HealthCare service contracts and warranty
  • Patient centric: Inclusive design ensures accessibility for all patients, reduces anxiety, and improves comfort with patient assisted compression
  • Advanced applications: 15-minute biopsy exam 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

“With Pristina Via with Recon DL, we’re setting a new benchmark in breast imaging — delivering sharper, clearer, and more consistent images 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.”

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Source- businesswire