Aiforia vs PathAI AISight

Neither vendor has an FDA-authorized AI diagnostic. PathAI's two clearances, K212361 and K243391, cover its image management system, and its algorithms are research use. Aiforia has no FDA clearance at all, though its CE-IVD prostate biopsy AI and clinical suite viewer can go into routine work in the EU today. A hospital department there that wants AI labeled for clinical use buys Aiforia, and PathAI is the weaker fit, because its CE-IVD mark covers the viewer.

A US department moving to digital primary diagnosis on FFPE slides buys AISight Dx. It works with the Hamamatsu NanoZoomer S360MD and the Leica Aperio GT 450 DX, and a change control plan lets PathAI add scanners without a new 510(k). PathAI is in the middle of a Roche acquisition at $750 million upfront. Aiforia is listed on Nasdaq First North in Helsinki, with a EUR 25.2M Series B in 2021 followed by later equity raises.