GE HealthCare Wins FDA Nod for Pristina Recon DL for Mammography

GE HealthCare has earned U.S. Food and Drug Administration (FDA) premarket authorization (PMA) for its Pristina Recon DL advanced 3D mammography image reconstruction technology.

Pristina Recon DL uses two deep learning models working in sequence to separate meaningful signal from noise. The first model reconstructs high-fidelity 3D volumes with more purity to minimize artifacts and perceived noise. The second model is trained to enhance the visualization of clinically relevant information in the DL synthesized view.

According to the company, Pristina Recon DL is the first mammography tech to use deep learning in combination with iterative reconstruction to offer digital breast tomosynthesis (DBT) image quality without compromising on patient dose. It uses NVIDIA RTX accelerated computing to execute its advanced image reconstruction.

A recent study showed that breast radiologists preferred Pristina Recon DL’s overall image quality in 99.1% of the image reviews compared to previous DBT reconstruction. In a trial with modeled clinical data, it was also shown to have superior performance in detecting microcalcification clusters and masses.

“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, Ph.D., 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.”

The company said a 15-minute biopsy exam with the Serena add-on device and diagnostic accuracy of contrast enhance 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, VP and GM, 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.”

Yesterday, the company revealed its Genesis Radiology Workspace, a solution designed to transform radiology workflows, unify the user experience, and provide radiologists with efficiency and precision.