Healthcare solutions provider GE HealthCare (Nasdaq: GEHC) announced on Wednesday that it has received U.S. FDA Premarket Authorization for Pristina Recon DL, a 3D mammography reconstruction technology powered by deep learning. The system delivers sharper images with fewer artifacts, enhanced detail, and greater consistency, supporting clinicians in more confident breast cancer diagnosis.

Pristina Recon DL uses two sequential deep learning models: the first reconstructs high-fidelity 3D volumes with minimal noise and artifacts, while the second enhances clinically relevant features in synthesized 2D views. Integrated with GE HealthCare's Pristina Via system and leveraging NVIDIA RTX accelerated computing, the technology offers rapid, precise image reconstruction without increasing patient dose.

Clinical evaluations indicate radiologists preferred Pristina Recon DL images in 99.1% of cases compared with conventional digital breast tomosynthesis. The system demonstrates superior detection of microcalcification clusters and masses and maintains the lowest 3D screening dose among major systems. Workflow efficiency features include zero-click acquisition, zero wait time, and patient-assisted compression for enhanced comfort.

GE HealthCare, a USD19.7bn global healthcare business employing approximately 53,000 staff, continues to innovate across medical technology, diagnostics, AI-enabled solutions and data analytics, aiming to advance connected, precise and patient-centred care.