The FDA gave Instrumentarium Imaging 510(k) clearance to market its Delta 32 3-D breast imaging system and digital stereotactic system. The system provides 3-D and layered viewing for assessment of biopsy depth and wire localization placement.The newly
The FDA gave Instrumentarium Imaging 510(k) clearance to market its Delta 32 3-D breast imaging system and digital stereotactic system. The system provides 3-D and layered viewing for assessment of biopsy depth and wire localization placement.
The newly approved items are part of Instrumentarium's Diamond Breast Care System. The stereotactic feature can image from any two angles, which gives it flexibility and saves procedure time. Although the system is film-based, an amorphous selenium full-field digital upgrade kit is in the works. n
Considering Breast- and Lesion-Level Assessments with Mammography AI: What New Research Reveals
June 27th 2025While there was a decline of AUC for mammography AI software from breast-level assessments to lesion-level evaluation, the authors of a new study, involving 1,200 women, found that AI offered over a seven percent higher AUC for lesion-level interpretation in comparison to unassisted expert readers.