Hologic Genius AI vs Subtle Medical

Subtle Medical sells scan enhancement to imaging departments: SubtleHD for MR, PET and CT, SubtleSYNTH, SubtleREFORMAT, and AiMIFY, built with Bracco for lower-gadolinium brain MRI. The vendor claims up to 80% faster MRI sequences, up to 75% faster PET scans and more than 1,300 scanners deployed. openFDA lists 11 510(k)s for the company, from SubtlePET in 2018 to SubtleHD-CT in May 2026. Hologic's product here is Genius AI Detection, a reader for breast tomosynthesis. The vendor reports 94% sensitivity from FDA documents, a 9% reader sensitivity gain and 70% fewer false markings than ImageChecker CAD in an internal comparison, and its footnotes say the analyses do not control type I error. An imaging center trying to shorten MR or PET slots takes Subtle, and a screening site reading tomosynthesis takes Hologic.