Aiforia Technologies plc (HEL:AIFORIA), a provider of AI-assisted medical software solutions, revealed on Thursday that it has obtained In Vitro Diagnostic Regulation (IVDR) certification, enabling the company to expand its AI-assisted medical software solutions in Europe.

This certification, granted by BSI Group, confirms Aiforia's compliance with IVD Regulation 2017/746 and supports the launch of three new CE-IVD marked AI models for breast and prostate cancer diagnostics.

CEO Jukka Tapaninen described the certification as a milestone that validates the safety, performance and risk management of Aiforia's clinical solutions. The company's AI models assist pathologists in cancer diagnostics, enhancing accuracy and efficiency in treatment decisions.

The Aiforia Breast Cancer HER2 AI model evaluates HER2 status in breast cancer tissue, while the Prostate Cancer Gleason 4 Cribriform and Perineural Invasion AI models detect key pathological patterns in prostate tissue samples. These tools are part of the Aiforia Breast Cancer Suite and Aiforia Prostate Cancer Suite, integrated with the Aiforia Clinical Suite Viewer for digital pathology analysis.

The IVDR framework strengthens regulatory oversight for diagnostic devices in the European Union, ensuring higher standards for patient safety and product quality.