Ibex Medical Analytics vs Indica Labs HALO AI

HALO AI is a research add-on, while Ibex Prostate Detect is a diagnostic device with FDA clearance K241232 from January 2025. A pathology department with a digital scanner workflow that wants a second read on prostate biopsies is Ibex's buyer, and the company offers an open API to scanners, image management and LIS. Its breast and gastric products are research use only in the US, by the vendor's statement. Ibex's products target breast, prostate and gastric tissue, which leaves a pharma group tuning classifiers on fluorescence slides better served by HALO AI, where segmentation, classification and phenotyping are tuned by example. Indica's FDA-cleared product is HALO AP Dx, a case-management viewer cleared with the Aperio GT 450 DX and the Hamamatsu NanoZoomer S360MD. HALO Prostate AI is CE-IVD marked with no US submission known, so a US lab cannot count on Indica for cleared prostate AI.