aetherAI vs Ibex Medical Analytics

A US lab adding an AI second read to prostate biopsies buys it from Ibex. Ibex Prostate Detect holds 510(k) K241232, decided in January 2025, and Urology Times, reporting the FDA summary, gives a 99.6% positive predictive value for heatmap accuracy and says pathologists without AI missed 13% of the cancers the AI found. The vendor labels its breast and gastric solutions research use in the US and says several carry a CE mark under IVDD. It also says its open API links to digital pathology software, scanners and LIS.

aetherSlide is a separate purchase. Its FDA record is a viewer clearance for FFPE slides, and the AI for prostate detection would come from elsewhere. A lab that needs a primary-diagnosis viewer, plus the slide quality control, cell counting and IHC quantification apps the vendor describes, is aetherAI's customer.