Aiforia finally obtained CE certification under the new regulation

Translation: Original published in Finnish on 2/20/2025 at 11:21 am EET.

Aiforia's CE markings, along with the rest of the industry, have been stuck since the end of May 2022 due to the EU's regulatory change for medical devices (IVDD -> IVDR). This regulatory barrier has finally been lifted as the company announced that it has now received IVDR certification under the new regulation, as well as CE-IVD markings for three new AI models (Breast Cancer HER2, Prostate Cancer G4 cribriform and PNI). This brings the Company's clinical portfolio from five AI models to eight models.

Paving the way for expansion of clinical partnerships and increasing the size of new deals

The news of the CE marking removes the long-standing uncertainty regarding the expansion of Aiforia's product portfolio in the clinical segment. In practice, the company will now be able to expand its existing clinical accounts in Europe, to whom it has previously sold a narrower range of AI models. Similarly, the company's new deals may be larger in the future, as Aiforia's pricing is based on the number of pathology samples processed with its models, and a wider range of models will bring more sample analyses to run through the company's software.

The news is obviously positive for Aiforia and signals the removal of one obstacle to its growth story. Now that the regulatory pipeline is open again, we expect the company to launch new models at least annually in the coming years. In line with the company's previous communication, we had already expected CE certifications under the new regulation towards the end of last year, so the news does not put any immediate pressure on our forecasts.