GE HealthCare's AI Mammography Tool Receives FDA Authorization

2025-11-27 digitalcare

Chicago, Thursday, 27 November 2025.
GE HealthCare’s Pristina Recon DL, an AI-driven mammography technology, received FDA authorization, offering enhanced 3D imaging for early breast cancer detection without increasing radiation dose.

Revolutionizing Breast Cancer Detection

On November 26, 2025, GE HealthCare announced that its Pristina Recon DL technology received premarket authorization from the U.S. Food and Drug Administration (FDA). This AI-driven mammography tool is designed to significantly enhance the quality of 3D breast imaging, playing a crucial role in early breast cancer detection without increasing the radiation dose to patients [1][2][3].

Advanced Imaging Technology

Pristina Recon DL utilizes sophisticated deep learning algorithms to improve image reconstruction by separating signals from noise, thus delivering clearer and more detailed 3D volumes. This technology is particularly effective in enhancing digital breast tomosynthesis (DBT) image quality. The integration of NVIDIA RTX accelerated computing further boosts the performance of these algorithms, offering high-resolution images that improve diagnostic confidence for radiologists [1][3][4].

Clinical Impact and Adoption

In clinical evaluations, Pristina Recon DL has shown remarkable results, with 99.1% of breast radiologists expressing a preference for its images over those produced by previous DBT methods. This preference underscores the technology’s potential to transform breast cancer diagnostics by providing radiologists with more reliable images, facilitating earlier and more accurate detection of breast cancer [1][4].

Patient-Centric Design

Beyond its technical capabilities, Pristina Recon DL emphasizes patient comfort and workflow efficiency. Features such as zero-click acquisition and personalized imaging protocols ensure a seamless experience for both patients and healthcare providers. The system’s design also boasts a 99% uptime, ensuring its reliability in high-volume screening environments [1][3].

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AI technology mammography