Ibex Medical Analytics Achieves CE-IVDR Certification for Breast Panel IHCs, Elevating the Standard of Care in AI-Powered Breast Cancer Diagnostics
Ibex Medical Analytics (Ibex), the global leader in AI-powered pathology solutions for clinical diagnostics and biopharma, today announced that it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for Ibex Breast ER, PR and Ki67. This milestone solidifies Ibex’s position as the market leader in breast cancer diagnostics by rounding out regulatory approval for its entire breast portfolio, which delivers unprecedented value to pathologists, laboratories, and patients. Covering biopsies and excisions, the breast suite comprises a fully IDVR-certified, end-to-end workflow across H&E, HER2, ER, PR, and Ki67-stained whole slide images. This was achieved following clinical studies and a meticulous review process, as required by EU regulations, reflecting trust in the quality, safety and performance of the product.
