Aiforia secures another CE-IVD mark
Summary
- Aiforia has launched a new CE-IVD-marked AI solution for prostate cancer diagnostics, following a similar tool for gastric cancer, supporting growth forecasts.
- The solution is built on Aiforia's Foundation Engine technology, which ensures reliable operation despite sample quality variations, crucial for routine clinical use.
- Expanding the clinical product portfolio aligns with Aiforia's growth strategy, aiming for 80% coverage of the diagnostic workflow by 2030, with expected revenue growth to 5.1 MEUR in 2026.
- The expanding portfolio of CE-IVD-marked solutions is key to attracting new customers and strengthening Aiforia's position as a European market leader in AI solutions for clinical digital pathology.
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Translation: Original published in Finnish on 3/18/2026 at 7:00 am EET.
Aiforia announced on Tuesday that it has released a new CE-IVD-marked AI solution for prostate cancer diagnostics. The Aiforia® Prostate Cancer Biopsy solution is intended for the analysis of prostate biopsies. The news follows the recently announced similar tool for gastric cancer diagnostics. The launch of the new model supports our growth forecasts.
The Foundation Engine is churning out new models
The new prostate cancer diagnostics solution is built on Aiforia's Foundation Engine technology. A key advantage of the technology is its ability to operate reliably despite variations in sample material quality, staining, or scanning. This is critical in routine clinical use, where sample quality can vary significantly. The solution is CE-IVD marked in accordance with the IVDR and integrates with the company's Clinical Suite Viewer software. Prostate cancer is one of the most common types of cancer, so effective and accurate diagnostic tools address a clinical need and support the work of pathologists. The product now released is a continuation of the gastric cancer diagnostics solution announced in February, which was also developed on the Foundation Engine platform. The use of the platform appears to be yielding rapid results in Aiforia's product development.
Product portfolio is expanding in line with the company's goals
Expanding the clinical product portfolio is a key part of Aiforia's growth strategy. The company aims to achieve around 80% coverage of the pathologist's diagnostic workflow by 2030. While a single product launch does not change our forecasts, it is a necessary step for the strong growth we predict to materialize. We expect Aiforia's revenue to grow to 5.1 MEUR in 2026, representing a 45% increase from the previous year. The expanding portfolio of CE-IVD-marked solutions is an important factor in winning new customers and expanding existing customer accounts. We believe the announcement helps Aiforia maintain and strengthen its position as the European market leader in AI solutions for clinical digital pathology.
