FDA Authorizes GE HealthCare's Pristina Recon DL for 3D Mammography
GE HealthCare has received FDA Premarket Authorization for Pristina Recon DL, a deep learning-based image reconstruction technology for digital breast tomosynthesis (DBT). The software enhances the Pristina Via system and is the first mammography solution to combine deep learning with iterative reconstruction for DBT image quality. It runs on NVIDIA RTX accelerated computing for fast reconstruction.
What's new
Pristina Recon DL uses artificial intelligence to deliver sharper images with fewer artifacts and improved detail. It integrates directly into existing Pristina Via workflows, aiming to strengthen clinical confidence without slowing down acquisition or reading.
How it works
The pipeline uses two deep learning models in sequence. The first reconstructs high-fidelity 3D volumes, minimizing artifacts and perceived noise. The second enhances visualization of clinically relevant features in the synthesized 2D view.
Clinical readout
In a study of 140 cases, eight MQSA-approved radiologists (trained on clinical image quality by the American College of Radiology) preferred images from Pristina Recon DL in 99.1% of reviews versus prior DBT reconstruction. The preference signal suggests clearer structure depiction and cleaner backgrounds, which may support more confident reads.
Leadership perspectives
Jyoti Gupta, PhD, President and CEO, Women's Health and X-ray at GE HealthCare, said the goal is high image quality, faster workflows, and greater confidence in early cancer detection. RadNet's CEO, Dr. Howard Berger, noted that the new 3D image quality is a meaningful upgrade for radiologists and patients.
Workflow and uptime
The Pristina Via with Recon DL setup supports zero-click acquisition within protocols and near-instant readiness-2.3 seconds from end of exposure to system ready in DBT. Reported uptime is 99%, based on 42,543 service requests from October 2023 to September 2024. The platform also supports a 15-minute biopsy exam with the Serena add-on device and Contrast Enhanced Mammography via SenoBright HD.
Why it matters
Breast cancer remains common-about one in eight women will face a diagnosis over their lifetime. For context on incidence and screening, see the National Cancer Institute's resources.
Projections estimate roughly 1.1 million breast cancer-related deaths annually by 2050. Any technology that delivers cleaner images and smoother workflows can help clinicians focus on earlier detection and more precise follow-up.
Availability and integration
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.
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