GE HealthCare has received FDA Premarket Authorization for Pristina Recon DL, a deep learning-based image reconstruction technology for 3D mammography. The technology uses artificial intelligence to deliver sharper images with fewer artifacts and enhanced details.
Pristina Recon DL is an enhancement to GE HealthCare’s Pristina Via system and is the first mammography technology to use deep learning in combination with iterative reconstruction for digital breast tomosynthesis image quality. The system utilizes NVIDIA RTX accelerated computing technology for image reconstruction.
“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,” said Jyoti Gupta, PhD, President and CEO, Women’s Health and X-ray at GE HealthCare.
The technology leverages two deep learning models working in sequence. The first model reconstructs high fidelity 3D volumes, minimizing artifacts and perceived noise. The second model enhances visualization of clinically relevant information in the synthesized 2D view.
A study showed that Pristina Recon DL overall image quality was preferred by breast radiologists in 99.1% of image reviews compared to previous digital breast tomosynthesis reconstruction. The study was performed on 140 cases with 8 MQSA-approved radiologists trained on clinical image quality by the American College of Radiology.
“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.
Breast cancer remains one of the most common cancers among women, with one in eight expected to face a diagnosis in their lifetime, according to the National Cancer Institute. An estimated 1.1 million breast cancer-related deaths are projected annually by 2050.
The Pristina Via with Recon DL system offers zero-click acquisition within protocols, zero wait time with 2.3 seconds elapsed time between end of exposure and system ready in digital breast tomosynthesis, and 99% uptime based on analysis of 42,543 service requests from October 2023 to September 2024.
The system includes a 15-minute biopsy exam with Serena add-on device and Contrast Enhanced Mammography with SenoBright HD. Pristina Recon DL is available as an upgradable feature on the Pristina Via platform.
GE HealthCare developed and validated the algorithms with academic institutions and high-volume outpatient imaging centers.
