GE HealthCare Reports the FDA Premarket Authorization of Pristina Recon DL for Mammography

Shots: 

• The US FDA has granted PMA to Pristina Recon DL, enabling the integration of deep learning with iterative reconstruction to deliver high-quality digital breast tomosynthesis (DBT) images without increasing patient radiation dose
• Pristina Recon DL utilizes 2 sequential deep learning models to separate signal from noise, with the first model reconstructing high-fidelity 3D volumes & the second enhancing clinically relevant details in synthesized 2D views
• In a study, Pristina Recon DL was preferred by radiologists in 99.1% of image reviews over prior DBT reconstruction & also demonstrated superior detection of microcalcification clusters & masses in a trial with modeled clinical data

Ref: GE HealthCare | Image: GE HealthCare | Press Release

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