GE HealthCare Receives FDA Authorization for Pristina Recon DL Deep Learning Mammography Technology

GE HealthCare has received FDA Premarket Authorization for Pristina Recon DL, a new deep learning image reconstruction application for 3D mammography. The technology is designed to improve image sharpness, reduce artifacts, and deliver more consistent visualization, aiming to support earlier and more accurate breast cancer detection.

Breast cancer remains one of the most common cancers among women worldwide, and global mortality is expected to rise significantly by 2050. With these trends in mind, GE HealthCare developed Pristina Recon DL to enhance digital breast tomosynthesis by separating useful signal from noise through a two-stage deep learning process. One model reconstructs high-fidelity 3D volumes, while the second improves the synthesized 2D views used in clinical interpretation.

Pristina Recon DL is an enhancement to the company’s Pristina Via system and combines deep learning with iterative reconstruction to improve image quality without raising radiation dose. Powered by NVIDIA RTX computing technology, the platform produces images quickly for real-time use in the exam room. “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 of Women’s Health and X-ray at GE HealthCare. She added that the technology aims to support confidence in early cancer detection.

Clinical evaluations suggest strong performance advantages. In one comparison study, breast radiologists preferred images generated with Pristina Recon DL in more than 99% of reviews. Additional testing showed improved detection of microcalcification clusters and masses, two key indicators of breast cancer. Dr. Howard Berger, President and CEO of RadNet, said the technology represents “a meaningful upgrade that will benefit radiologists and patients alike,” noting that improved clarity can help support more confident diagnoses.

Developed in collaboration with academic centers and high-volume imaging practices, the system is available as an upgrade to existing Pristina Via platforms. GE HealthCare says Pristina Recon DL was designed to fit into established mammography workflows while improving image quality and maintaining patient comfort. Dr. Gary Dee, President of Midstate Radiology Associates, said upgrading to Pristina Via had already improved workflow efficiency, adding that the new reconstruction capability delivers “a new level of image quality that reinforces our confidence in delivering breast cancer care.”