FDA, CE & Health Canada | Breast | FFDM | Amplifier Partner

Description of use

Lunit INSIGHT MMG generates (1) the location of breast cancer in the form of heatmaps and/or contour maps, (2) an abnormality score reflecting the probability of the existence of breast cancer, and (3) assessment of breast density.

Lunit INSIGHT MMG provides six major user benefits:

  • Reduced false-positive and false-negative recalls
    AI-aided, improved detection accuracy for mammography reduces false-positive recalls by 14% and false-negative recalls by 18%, allowing radiologists to order breast MRI and biopsies only when it’s needed. In addition, they can detect more interval and future screening-detected cancers that could have been interpreted as negative.
  • Fast triage of normal cases
    According to the abnormality scores generated by AI, radiologists can successfully triage up to 60% of the entire cases without human interpretation, which can reduce their workload by more than half in mammogram interpretation.
  • Improved reading performance of general radiologists
    General radiologists can use the AI analysis results to improve their reading performance by up to 18%, to a level up to that of breast specialists.
  • Early diagnosis of breast cancer
    Radiologists can detect T1 and node-negative breast cancer with 91% and 87% accuracy, respectively.
  • Support for decision-making on BI-RADS 3 and 4 cases
    For complicated, hard-to-conclude cases classified as BI-RADS 3 or 4, radiologists can compare their reading result with the abnormality scores and decide with confidence whether or not to order additional exams such as ultrasound and biopsy.
  • Improved diagnostic accuracy for dense breasts
    Radiologists can improve their diagnostic accuracy for dense and fatty breasts by up to 9% and 22%, respectively.

The application content is provided by the respective AI vendors.