Radboudumc and partners Aiosyn achieves IVDR CE marking for mitosis counting with AI

9 January 2025

Aiosyn, a Radboudumc spin-off and pioneering innovator in AI-powered pathology software for cancer and kidney disease, has announced that its algorithm for mitotic figure counting has achieved CE marking under the In Vitro Diagnostic Regulation (IVDR) for use in diagnostics. This milestone establishes Aiosyn Mitosis Breast as the first IVDR-certified application for mitosis counting in breast cancer diagnostics and accelerates the company’s growth in clinical pathology.

 

Read the full news release at Aiosyn Mitosis Breast becomes the first AI-powered mitosis detection solution to achieve CE mark certification under IVDR - Aiosyn

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