Translation: Original published in Finnish on 6/24/2025 at 1:41 pm EEST.

Aiforia announced a new CE-IVD marking for its clinical AI solution for breast cancer classification. According to the company, the approved AI solution automates breast cancer classification by supporting pathologists with five separate AI models. The solution accurately identifies invasive carcinoma and ductal carcinoma in situ variant (DCIS). In addition, it identifies and objectively counts the number of mitoses, tubule formation, and nuclear atypia according to the Nottingham classification system. Prior to the now approved solution, Aiforia already had four models supporting breast cancer diagnostics (KI-67, ER and PR cells, HER-2 classification).

This solution is Aiforia's ninth to receive CE-IVD approval in Europe. However, unlike previous approvals, the solution includes five separate AI models, so the approval significantly expands the company's product portfolio (8 models + 1 viewer -> 13 models + 1 viewer). The approval increases the potential scale of the company's new customer agreements and also enables larger expansions for existing customers. The release supports our view that the company's revenue growth will accelerate during the current year, as well as supporting the company's competitive position in a rapidly emerging market.