Gleamer vs ScreenPoint Transpara

Gleamer lists a mammography product, BreastView, on gleamer.ai. BreastView does not appear among the openFDA records under Gleamer's applicant names, which cover BoneView, BoneMetrics, ChestView US and Pixyl.Neuro. Those cleared products suit a hospital trauma service reading fractures and chest films.

For a US breast imaging center on tomosynthesis, Gleamer loses. ScreenPoint says Transpara is FDA cleared for 2D and 3D mammography, and openFDA lists eight Transpara 510(k) records, the latest K260898 on August 14, 2026, one of them the density tool K232096.

Screening programs and breast centers reading 2D or 3D mammograms with single or double reading are Transpara's fit. ScreenPoint says the Swedish MASAI trial used it and reports sensitivity of 80.5% against 73.8% for standard double reading at 98.5% specificity across more than 105,000 women. MASAI compared AI-supported reading with standard double reading.