Aiforia vs Indica Labs HALO AI

Indica Labs sells three things under the HALO name, and one is FDA-cleared. HALO AP Dx holds 510(k) K232833 from May 2024 and K252762 from November 2025 for primary diagnosis, cleared with the Aperio GT 450 DX and the Hamamatsu S360MD. HALO Prostate AI is CE-IVD, and HALO AI itself is a research classifier trained by example. Leica Biosystems resells Indica's image management products and invested in January 2025. That suits a US lab buying through Leica, since Aiforia has no FDA clearance.

A European hospital lab wanting CE-IVD prostate AI plus clinical suites for breast, lung, colon and gastric work goes to Aiforia, and Indica comes second for it, since HALO Prostate AI is the only CE-IVD tool Indica names. Aiforia publishes SOC 2 Type II and ISO 27001, while Indica states no SOC 2 or HITRUST report on its pages, which decides it for a university group facing a security review. Both let such a group build its own classifiers.